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Training Courses and Conferences

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Science and laboratory conferences, conventions, seminars, training courses and annual meetings in microbiology, toxicology, preclinical, food science, analytical chemistry, pharmaceuticals, bioanalytical, genetics, immunology, etc.

Learn and network with colleagues ! Global Regulatory .com's Regulatory Training Courses and Conferences Database feature regulatory related expositions, annual meetings, trade shows, conferences, courses, webinars, workshops, training, EXPO's and seminars in a variety of regulated industries from pharmaceuticals, biotechnology, food, medical devices, life sciences, healthcare, telecommunications, consumer products, textiles, transportation, oil and gas, electronics, plastics, automotive, defense, power and energy, chemicals, aerospace, animal health, etc.

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2007 Regulatory Training Courses and Conferences
start date
sponsor
regulatory training courses and conferences description.
 location .
01/08/2007
15th International Conference on Organic Process Research & Development
15th International Conference on Organic Process Research & Development
Course or Conference Sponsor: Scientific Update
The conversion of a chemical process into a process for manufacture on tonnage scale is of vital importance in the Chemical and Pharmaceutical industries, both from an economi Read More...		 CA, USA
01/14/2007
6th Annual DIA Conference for Contemporary Pharmacovigilance and Risk Management Strategies
 6th Annual DIA Conference for Contemporary Pharmacovigilance and Risk Management Strategies
Course or Conference Sponsor: Drug Information Association (DIA)
The field of medical product safety continues to grow in complexity, with both clinical trial safety and postmarketing pharmacovigilance becoming ever more critical in the dev Read More...		 DC, US
01/18/2007
European Regulatory Affairs
 European Regulatory Affairs
Course or Conference Sponsor: Drug Information Association (DIA)
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1 Read More...		 CA, USA
01/21/2007
Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
 Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
Course or Conference Sponsor: Drug Information Association (DIA)
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an over Read More...		 CA, USA
01/21/2007
Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
 Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
Course or Conference Sponsor: Drug Information Association (DIA)
This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the Read More...		 CA, USA
01/24/2007
Sharing Data and Models to Improve Clinical Drug Development and Regulatory Decisions
 Sharing Data and Models to Improve Clinical Drug Development and Regulatory Decisions
Course or Conference Sponsor: Drug Information Association
Clinical trial failure in late development (Phase 3) is a risk that companies cannot afford, particularly if the failure is predictable. The FDA Critical Path Opportunities Li Read More...		 DC, USA
01/24/2007
Sharing Knowledge to Improve Clinical Drug Development and Regulatory Decisions: Data/models of Diseases, Drugs, Placebo, Baseline, and Dropouts
 Sharing Knowledge to Improve Clinical Drug Development and Regulatory Decisions: Data/models of Diseases, Drugs, Placebo, Baseline, and Dropouts
Course or Conference Sponsor: Drug Information Association (DIA)
Clinical trial failure in late development (Phase 3) is a risk that companies cannot afford, particularly if the failure is predictable. The FDA Critical Path Opportunities Li Read More...		 DC, USA
01/25/2007
Pharmaceutical Marketing and Sales
 Pharmaceutical Marketing and Sales
Course or Conference Sponsor: C5
The legal and regulatory environment in which pharmaceutical companies operate is becoming more onerous than ever before. One of the areas coming under most increased scrutiny Read More...		 , Switzertland
02/06/2007
1987-2007 - EDM's 20th Anniversary Conference: Reconnecting the Process to the Delivery of Safe and Effective Medical Products
 1987-2007 - EDM's 20th Anniversary Conference: Reconnecting the Process to the Delivery of Safe and Effective Medical Products
Course or Conference Sponsor: Drug Information Association (DIA)
Over the past 20 years, the DIA EDM Conference has served as a platform for the discussion of emerging standards and processes for the creation, submission and retention of re Read More...		 PA, USA
02/08/2007
Regulations for Nanotechnology in Consumer Products
 Regulations for Nanotechnology in Consumer Products
Course or Conference Sponsor: Intertech-Pira
Join Intertech-Pira for this groundbreaking conference as we explore and define the rules for governing nanotechnology. What you'll learn at this breakthrough conference: Read More...		 DC, USA
02/12/2007 to 02/13/2007
CMC Submissions in CTD Format
 CMC Submissions in CTD Format
Course or Conference Sponsor: The Center for Professional Advancement
This course is intended for all personnel in pharmaceutical companies especially those in: Regulatory Affairs Chemistry and Analytical Departments Pre-formulation Pha Read More...		 NJ, USA
02/19/2007
The 6th Pharmaceutical Powder X-ray Diffraction Symposium
 The 6th Pharmaceutical Powder X-ray Diffraction Symposium
Course or Conference Sponsor: Interntational Center for Diffraction Data
The International Centre for Diffraction Data (ICDD) is proud to present PPXRD-6 in Barcelona, Spain. This three day training on up to date issues in XRD in the pharmaceutical Read More...		 , Spain
02/20/2007
19th Annual Conference on Marketing Pharmaceuticals in a Time of Change
 19th Annual Conference on Marketing Pharmaceuticals in a Time of Change
Course or Conference Sponsor: Drug Information Association (DIA)
This program is designed both for people who are new to advertising and promotion issues, as well as those who have been involved in this area for some time. It is designed to Read More...		 NY, USA
02/26/2007
The Advaced Legal, Regulatory and Commercial Guide to Medical Advices
 The Advaced Legal, Regulatory and Commercial Guide to Medical Advices
Course or Conference Sponsor: C5
Hear from high-profile experts and authoritative industry players who will offer practical and comprehensive information and insights from their own experiences on:  Publi Read More...		 , Germany
02/26/2007 to 02/28/2007
Preparation, Packaging and Labeling of Clinical Trial Materials
 Preparation, Packaging and Labeling of Clinical Trial Materials
Course or Conference Sponsor: The Center for Professional Advancement (CFPA)
This introductory survey course will emphasize the procedures and techniques needed to prepare compliant clinical trial supplies. The course is intended for personnel who are Read More...		 , The Netherlands
03/04/2007
18th Annual Workshop on Medical Communications: Medical Information, Medical Liaisons, Contact Centers
 18th Annual Workshop on Medical Communications: Medical Information, Medical Liaisons, Contact Centers
Course or Conference Sponsor: Drug Information Association
CONFERENCE HIGHLIGHTS Sunday, March 4 Core Curriculum - in-depth discussions, case studies, roundtable discussions Welcome Reception - casual atmosphere for meeting and n Read More...		 CA, USA
03/05/2007 to 03/07/2007
Documentation Management and Control
 Documentation Management and Control
Course or Conference Sponsor: The Center for Professional Advancement
This basic introductory course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries. The course will b Read More...		 NJ, USA
03/12/2007 to 03/14/2007
INDs, NDAs vs CTDs Global Regulations
 INDs, NDAs vs CTDs Global Regulations
Course or Conference Sponsor: The Center for Professional Advancement
This course is specifically designed for personnel in the pharmaceutical and biotechnology industries who need a detailed understanding of what comprises an IND, NDA, BLA, AND Read More...		 CA, USA
03/19/2007
Clinical Data Management
 Clinical Data Management
Course or Conference Sponsor: Drug Information Association (DIA)
This course is designed for data management professionals who have less than one year of pharmaceutical or related industry experience. It combines lectures and in-depth discu Read More...		 FL, USA
03/19/2007 to 03/22/2007
Granulation, Tabletting and Capsule Technology
 Granulation, Tabletting and Capsule Technology
Course or Conference Sponsor: The Center for Professional Advancement
This broadly based course is intended for all scientists and technologists concerned with the development and processing of tablets, capsules and similar products, and with re Read More...		 FL, USA
03/20/2007
EudraVigilance: Medicinal Product Dictionary
 EudraVigilance: Medicinal Product Dictionary
Course or Conference Sponsor: Drug Information Association (DIA)
The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Direct Read More...		 London, United Kingdom
03/21/2007
Non-Clinical Drug Safety Evaluation and Drug Development
 Non-Clinical Drug Safety Evaluation and Drug Development
Course or Conference Sponsor: Center for Professional Advancement (CFPA)
This course is designed for a broad range of pre-clinical, clinical, management, investment, and regulatory personnel in both established and emerging pharmaceutical companies Read More...		 NJ, USA
03/21/2007 to 03/23/2007
Non-Clinical Drug Safety Evaluation and Drug Development
 Non-Clinical Drug Safety Evaluation and Drug Development
Course or Conference Sponsor: The Center for Professional Advancement
This course is designed for a broad range of pre-clinical, clinical, management, investment, and regulatory personnel in both established and emerging pharmaceutical companies Read More...		 NJ, USA
03/26/2007
System Validation, GAMP Harmonization and P.A.T
System Validation, GAMP Harmonization and P.A.T
Course or Conference Sponsor: The Center for Professional Advancement (CFPA)
 This course is designed for both users and developers of FDA regulated systems, especially personnel involved in Conducting Clinical Studies Laboratory Analysis Qu Read More...		 FL, USA
03/26/2007
Regulatory I Training Course
 Regulatory I Training Course
Course or Conference Sponsor: Drug Information Association (DIA)
The course will focus on drug and well-characterized biological products and not the regulatory process for devices or generic products. This course describes the regulatory b Read More...		 PA, USA
03/26/2007 to 03/28/2007
System Validation, GAMP Harmonization and P.A.T
 System Validation, GAMP Harmonization and P.A.T
Course or Conference Sponsor: The Center for Professional Advancement
This course is designed for both users and developers of FDA regulated systems, especially personnel involved in Conducting Clinical Studies Laboratory Analysis Quality Read More...		 FL, USA
03/27/2007
Implementing FDA's New Quality Systems Approach to Pharmaceutical cGMP Regulations
 Implementing FDA's New Quality Systems Approach to Pharmaceutical cGMP Regulations
Course or Conference Sponsor: Institute of Validation Technology (IVT)
Underscoring Successful Implementation Strategies for Today's Quality System ✔ Create a robust strategy for implementing quality by design, continuous improvement, a Read More...		 PA, USA
03/28/2007
Uranium Africa 2007
 Uranium Africa 2007
Course or Conference Sponsor: International Quality and Productivity Center
With the spot price of uranium having more than trebled to $60/ lb in the past three years, now is the time for mining and exploration companies for whom uranium mining was pr Read More...		 , Gauteng
04/16/2007
Drug Safety Surveillance Training Course
 Drug Safety Surveillance Training Course
Course or Conference Sponsor: Drug Information Association (DIA)
This course is designed to provide an overview of US and international safety surveillance, including the role of epidemiology and risk management, from both industry and FDA Read More...		 PA, USA
04/16/2007
International GMPs:Complying with GMP Requirements in the US, EU and Japan
 International GMPs:Complying with GMP Requirements in the US, EU and Japan
Course or Conference Sponsor: Pharmaceutical Training Insttute - PTi - International
Improve your ability to:  Clarify the similarities and differences among GMP requirements for the U.S., EU and Japan and create a globally compliant manufacturing process Read More...		 DC, USA
04/22/2007
ASME 15th International Conference on Nuclear Engineering (ICONE15)
 ASME 15th International Conference on Nuclear Engineering (ICONE15)
Course or Conference Sponsor: American Society Of Mechanical Engineers (ASME)
Topics covered at ICONE 15 include: Plant Operations Installations, Maintenance and Life Cycle Component Reliability and Materials Issues Near Term Deployment and Pr Read More...		 Nagoya, Janpa
04/23/2007
Regulatory Affairs: Part I: The IND Phase & Part II: The CTD/NDA Phase
 Regulatory Affairs: Part I: The IND Phase & Part II: The CTD/NDA Phase
Course or Conference Sponsor: Drug Information Association (DIA)
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an over Read More...		 PA, USA
04/30/2007
European Regulatory Affairs Training Course: An In-Depth Review of Registration Procedures in the European Union
 European Regulatory Affairs Training Course: An In-Depth Review of Registration Procedures in the European Union
Course or Conference Sponsor: Drug Information Association (DIA)
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 19 Read More...		 PA, USA
05/07/2007
Global Regulatory Affairs: Overview of Drugs and Biologics
 Global Regulatory Affairs: Overview of Drugs and Biologics
Course or Conference Sponsor: The Pharmaceutical Education and Research Institute (PERI)
This course will provide a comprehensive overview of US/FDA, European, Canadian, Australian and Rest-of-World (ROW)/emerging market regulations for drugs and biologics develop Read More...		 PA, USA
05/17/2007
Aseptic Processing Controls & Compliance
 Aseptic Processing Controls & Compliance
Course or Conference Sponsor: Institute of Validation Technology (IVT)
The conference will offer an in-depth look at many facets of aseptic processing and microbiology. Attendees will gain invaluable knowledge in techniques of most current intere Read More...		 MD, USA
06/04/2007
Software Development for Medical Device Professionals
 Software Development for Medical Device Professionals
Course or Conference Sponsor: The Center for Professional Innovation & Education
This continually updated course covers current FDA regulatory compliance with respect to developing medical device software. A focus will be placed on both the regulation and Read More...		 PA, USA
06/04/2007
The CTD: Recommended Format and Implementation of the ICH Common Technical Document for Marketing Application Submissions
 The CTD: Recommended Format and Implementation of the ICH Common Technical Document for Marketing Application Submissions
Course or Conference Sponsor: The Center for Professional Innovation & Education
The course on the CTD will provide applicants with the information needed to prepare a marketing application submission that is in compliance with regulatory agency recommenda Read More...		 PA, USA
06/06/2007
The CTD: Recommended Format and Implementation of the ICH Common Technical Document for Marketing Application Submissions
 The CTD: Recommended Format and Implementation of the ICH Common Technical Document for Marketing Application Submissions
Course or Conference Sponsor: The Center for Professional Innovation & Education
The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Included in the course content is Read More...		 California, USA
06/13/2007
Generic Drug Approvals - Preparing an ANDA for First-Cycle Approval
 Generic Drug Approvals - Preparing an ANDA for First-Cycle Approval
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course provides comprehensive and up-to-date knowledge of the preparation of an Abbreviated New Drug Application (ANDA) to the U.S. FDA Office of Generic Drugs. The cours Read More...		 California, USA
06/14/2007
Introduction to Effective Medical Writing
 Introduction to Effective Medical Writing
Course or Conference Sponsor: The Center for Professional Innovation & Education
Who Should Attend This course is valuable to those who write or review documentation in support of clinical trials and regulatory submissions. It will also benefit profess Read More...		 California, USA
06/17/2007
43rd DIA Annual Meeting
 43rd DIA Annual Meeting
Course or Conference Sponsor: Drug Information Association
The DIA Annual Meeting is the "event to attend" each year for biotechnology, pharmaceutical, and regulatory professionals. No other industry meeting of its kind can rival the Read More...		 GA, USA
06/17/2007
43rd DIA Annual Meeting
 43rd DIA Annual Meeting
Course or Conference Sponsor: Drug Information Association (DIA)
The DIA Annual Meeting is the "event to attend" each year for biotechnology, pharmaceutical, and regulatory professionals. No other industry meeting of its kind can rival the Read More...		 GA, USA
06/18/2007
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
 CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Course or Conference Sponsor: The Center for Professional Innovation & Education
This three day course will present a strategy to obtain a cost-effective, risk-managed CMC regulatory compliance especially useful for all stages of clinical development and f Read More...		 California, USA
06/20/2007
Global Regulations for Cosmetics
 Global Regulations for Cosmetics
Course or Conference Sponsor: Intertech-Pira
The development of cosmetic products for the global market presents many challenges to the product development and regulatory personnel of the companies involved, both in maki Read More...		 DC, USA
06/26/2007
EudraVigilance: Medicinal Product Dictionary
 EudraVigilance: Medicinal Product Dictionary
Course or Conference Sponsor: Drug Information Association (DIA)
The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Direct Read More...		 London, United Kingdom
07/09/2007
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
 Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course presents the technical fundamentals that govern aseptic processing operations and provides sufficient practical advice for attendees to effectively troubleshoot an Read More...		 California, USA
07/12/2007
Drug Master Files - Understanding and Meeting your Regulatory
 Drug Master Files - Understanding and Meeting your Regulatory
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants Read More...		 California, USA
08/06/2007
Regulatory Affairs Training Course: Part I and II
 Regulatory Affairs Training Course: Part I and II
Course or Conference Sponsor: Drug Information Association (DIA)
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an over Read More...		 MA, USA
08/06/2007
 Pharmaceutical cGMPs and FDA Inspections
Course or Conference Sponsor: The Center for Professional Advancement (CfPA)
This course will introduce you to Current Good Manufacturing Practice (cGMP) in the pharmaceutical and allied industries. Topics covered will include not only the legal requir Read More...		 NJ, USA
08/07/2007
The European UnionClinical Trial Directive
 The European UnionClinical Trial Directive
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process. The Course covers all rele Read More...		 California, USA
08/08/2007
Adverse Drug Events - Understanding and Reporting Requirements
 Adverse Drug Events - Understanding and Reporting Requirements
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and report Read More...		 California, USA
08/08/2007
Adverse Drug Events - Understanding and Reporting Requirements
 Adverse Drug Events - Understanding and Reporting Requirements
Course or Conference Sponsor: The Center for Professional Innovation & Education
Who Should Attend This two-day course is designed for those involved with Clinical Research, Safety Surveillance, Regulatory Affairs, Clinical Trials, Medical Affairs and Q Read More...		 California, USA
08/09/2007
Effective Risk-Based Applications of cGMPs to Cosmetics and OTC Drug Products (No Dosage) Produced by Cosmetic Manufacturers
 Effective Risk-Based Applications of cGMPs to Cosmetics and OTC Drug Products (No Dosage) Produced by Cosmetic Manufacturers
Course or Conference Sponsor: The Center for Professional Innovation & Education
Upon completion of this course attendees will have a clear understanding of regulatory agency expectations for the manufacture of Cosmetic Products in comparison to OTC Drug r Read More...		 PA, USA
08/20/2007
Overview of Drug Development Training Course
 Overview of Drug Development Training Course
Course or Conference Sponsor: Drug Information Association (DIA)
This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, Read More...		 NJ, USA
08/21/2007
How to Monitor Clinical Trials for Good Clinical Practice (GCP) Compliance
 How to Monitor Clinical Trials for Good Clinical Practice (GCP) Compliance
Course or Conference Sponsor: The Center for Professional Innovation & Education
This training course provides a solid understanding of Good Clinical Practice GCP requirements and clinical quality assurance overviews for clinical trials. Attendees will ga Read More...		 PA, USA
08/27/2007
Preparing the CMC Section for NDAs/INDs
 Preparing the CMC Section for NDAs/INDs
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course provides participants with a thorough understanding of the requirements for each CMC section of the Common Technical Document (CTD), i.e., the format to be used fo Read More...		 California, USA
08/27/2007
European Regulatory Affairs Training Course
 European Regulatory Affairs Training Course
Course or Conference Sponsor: Drug Information Association (DIA)
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 19 Read More...		 IL, USA
09/06/2007
Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
 Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course is designed for those who perform, supervise, manage, audit, or oversee the validation of analytical methods for the quality control of small molecule pharmaceutic Read More...		 , Ireland
09/17/2007
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
 CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Course or Conference Sponsor: The Center for Professional Innovation & Education
This three day course will present a strategy to obtain a cost-effective, risk-managed CMC regulatory compliance especially useful for all stages of clinical development and Read More...		 PA, USA
09/18/2007
EudraVigilance: Medicinal Product Dictionary
 EudraVigilance: Medicinal Product Dictionary
Course or Conference Sponsor: Drug Information Association (DIA)
The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Direct Read More...		 London, United Kingdom
09/19/2007
Pharmaceutical Water Systems
 Pharmaceutical Water Systems
Course or Conference Sponsor: The Center for Professional Innovation & Education
The course will be valuable for those in pharmaceutical, biotechnology and medical device manufacturing who are responsible for or involved in:  Specification and engineerin Read More...		 PA, USA
09/20/2007
European Filing and Registration Procedures
 European Filing and Registration Procedures
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course specifically focuses on agencies that control the regulatory process. The course will cover topics relating to pre-clinical and clinical requirements, as well as, Read More...		 , Ireland
09/24/2007
Quality Systems Regulation for the Medical Device & Biotech Industries
 Quality Systems Regulation for the Medical Device & Biotech Industries
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course will introduce you to the Quality System Regulation in the medical devices and biotech industries. Topics covered will include not only the legal requirements for Read More...		 PA, USA
09/24/2007
Stability Testing of Proteins, Peptides, & Other Biomolecules
 Stability Testing of Proteins, Peptides, & Other Biomolecules
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course provides comprehensive and up-to-date knowledge of stability testing for quality assurance and control of protein and peptide biopharmaceuticals and biologics. The Read More...		 CA, USA
09/24/2007
The EU Clinical Trial Directive
 The EU Clinical Trial Directive
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process. The Course covers all rele Read More...		 , Ireland
09/27/2007
Pharmaceutical Water Systems
 Pharmaceutical Water Systems
Course or Conference Sponsor: The Center for Professional Innovation & Education
An interactive mix of lectures and discussions highlight basic principles and technologies, and how these are applied in practice to pharmaceutical water systems. The course i Read More...		 , Ireland
10/01/2007
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
 Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course presents the technical fundamentals that govern aseptic processing operations and provides sufficient practical advice for attendees to effectively troubleshoot an Read More...		 , Ireland
10/02/2007
IVT's Lab Week
IVT's Lab Week
Course or Conference Sponsor: Advanstar Communications/Institute of Validation Technology
IVT's Lab Week is a comprehensive guide to Method Validation, Laboratory Compliance, and Stability Testing. Hear 40+ presentations including FDA Keynote addresses on FDA's Read More...		 CA, USA
10/02/2007
Institute of Validation Technology 's Lab Week
Institute of Validation Technology 's Lab Week
Course or Conference Sponsor: Advanstar Communications/Institute of Validation Technology
Institute of Validation Technology's Lab Week is a comprehensive guide to Method Validation, Laboratory Compliance, and Stability Testing. Hear 40+ presentations including Read More...		 CA, USA
10/03/2007
Generic Drug Approvals - Preparing an ANDA for First-Cycle Approval
 Generic Drug Approvals - Preparing an ANDA for First-Cycle Approval
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course provides comprehensive and up-to-date knowledge of the preparation of an Abbreviated New Drug Application (ANDA) to the U.S. FDA Office of Generic Drugs. The cours Read More...		 , Ireland
10/04/2007
Effective Document Management for the Pharmaceutical, Biotech, and Medical Device Industries
 Effective Document Management for the Pharmaceutical, Biotech, and Medical Device Industries
Course or Conference Sponsor: The Center for Professional Innovation & Education
Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development should attend. Upon completion of this two-day course attendees Read More...		 PA, USA
10/08/2007
Excellence in Pharmacovigilance: Clinical Trials and Post marketing
 Excellence in Pharmacovigilance: Clinical Trials and Post marketing
Course or Conference Sponsor: DIA Drug Information Association
Overview: This course is designed to provide a firm grounding in key aspects of Global Clinical and Post Marketing Safety. This five-day training course, presented by the E Read More...		 , France
10/09/2007
How to Monitor Clinical Trials for GCP Compliance
 How to Monitor Clinical Trials for GCP Compliance
Course or Conference Sponsor: The Center for Professional Innovation & Education
This training course provides a solid understanding of GCP requirements and clinical quality assurance overviews for clinical trials. Attendees will gain experience in proven Read More...		 CA, USA
10/10/2007
Practical GCP Compliance Auditing of Trials & Systems
 Practical GCP Compliance Auditing of Trials & Systems
Course or Conference Sponsor: DIA Drug Information Association
Overview: This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemente Read More...		 , UK
10/10/2007
REACH: Registration, Evaluation and Authorization of Chemicals
REACH: Registration, Evaluation and Authorization of Chemicals
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course will provide an in depth overview of the REACH chemical program for professionals involved in chemical applications for all aspects of product development with bus Read More...		 NJ, USA
10/10/2007
End-to-End Supply Chain Management
 End-to-End Supply Chain Management
Course or Conference Sponsor: International Quality and Productivitry Center (IQPC)
End-to-End will be a forum for internal supply chain partners and external downstream partners to collaborate and discuss how to best implement technology and processes to imp Read More...		 ., The Netherlands
10/10/2007
Pharma Secure Chain
 Pharma Secure Chain
Course or Conference Sponsor: Internatioanl Quality and Productivity Center (IQPC)
Protect your patients, products and IP against counterfeiting and diversion by implementing effective security measures, authentication technology and track and trace initiati Read More...		 n/a, Netherlands
10/11/2007
HACCP: Verification and Record Keeping - An Introduction and Review (Third in a Three Part Series); An Online Course 11:00 a.m. - 12:30 p.m. (EST-New York time)
HACCP: Verification and Record Keeping - An Introduction and Review (Third in a Three Part Series); An Online Course 11:00 a.m. - 12:30 p.m. (EST-New York time)
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course presents a step-by-step approach to food safety using the Hazard Analysis and Critical Control Point system. The material presented is consistent with both U.S. na Read More...		 ,
10/11/2007
Writing SOPs for cGMP Compliance
 Writing SOPs for cGMP Compliance
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This two-day practical course is designed to detail a step-by step outline for writing "Standard Operating Procedures" and to adapt this outline for use in many specific appli Read More...		 NJ, USA
10/11/2007
4th Multi-track Workshop in Japan - Pursuing Global Joint Development, Drug Discovery and Fostering Promotion
4th Multi-track Workshop in Japan - Pursuing Global Joint Development, Drug Discovery and Fostering Promotion
Course or Conference Sponsor: DIA Drug Information Association
Overview Building a strong foundation for clinical development and training of investigators in Japan has become an important element of global development. In recent y Read More...		 , Japan
10/15/2007
Special Training Course on US Regulatory Affairs
 Special Training Course on US Regulatory Affairs
Course or Conference Sponsor: DIA Drug Information Association
Overview: This course is specifically designed for persons with a background in preclinical research (e.g., pharmacology, toxicology, and drug metabolism), clinical researc Read More...		 , UK
10/15/2007
Combination Product Development: Safety/Registration/Approval
Combination Product Development: Safety/Registration/Approval
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course provides a comprehensive explanation of the preclinical development of combination products emphasizing the principles and strategies associated with the integrati Read More...		 NJ, USA
10/15/2007
Pharmaceutical Quality Assurance and Control
Pharmaceutical Quality Assurance and Control
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course provides an understanding of the principles and practice of pharmaceutical quality assurance and control and of specific topics which have become important because Read More...		 NJ, USA
10/15/2007
Introduction to Effective Medical Writing
 Introduction to Effective Medical Writing
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course is valuable to those who write or review documentation in support of clinical trials and regulatory submissions. Well written submission documentation can decre Read More...		 PA, USA
10/16/2007
Science and Risk Based Approach to Commissioning, Qualification and Validation
Science and Risk Based Approach to Commissioning, Qualification and Validation
Course or Conference Sponsor: CFPA The Center for Professional Advancement
Because validation is the critical factor in achieving FDA approval of new and renovated facilities, it is essential that validated systems and equipment be commissioned using Read More...		 NJ, USA
10/16/2007
Medical Imaging Stakeholders Call for Action: Harmonization of Imaging Review Charters and Integration of Imaging in Therapeutic Development: Pharmaceutical Industry, CRO, FDA, and Allied Working Groups Collaborate for Regulatory Guidance
 Medical Imaging Stakeholders Call for Action: Harmonization of Imaging Review Charters and Integration of Imaging in Therapeutic Development: Pharmaceutical Industry, CRO, FDA, and Allied Working Groups Collaborate for Regulatory Guidance
Course or Conference Sponsor: DIA Drug Information Association
Program Overview Medical imaging stakeholders will collaborate for a call to action for harmonization and standardization of medical imaging in therapeutic development for Read More...		 MD, USA
10/16/2007
Adverse Drug Events in Premarketing Clinical Trials and Postmarketing Pharmacovigilance: The Compliance, Medical Assessment and Risk Management Continuum
 Adverse Drug Events in Premarketing Clinical Trials and Postmarketing Pharmacovigilance: The Compliance, Medical Assessment and Risk Management Continuum
Course or Conference Sponsor: DIA Drug Information Association
Overview: Clinical trial safety and postmarketing pharmacovigilance constitute a risk management continuum, in which a pharmaceutical's benefit/risk balance is monitored an Read More...		 PA, USA
10/17/2007
Statistical Methodology in Clinical R&D
 Statistical Methodology in Clinical R&D
Course or Conference Sponsor: DIA Drug Information Association
Overview: The workshop aims to provide the opportunity to listen to and interact with key opinion leaders and influential statisticians from regulatory agencies, academia a Read More...		 , Spain
10/18/2007
Drugs in Pregnancy - From Data to Risk Communication
 Drugs in Pregnancy - From Data to Risk Communication
Course or Conference Sponsor: DIA Drug Information Association
Overview: This workshop will provide a comprehensive approach of risk assessment and risk management of medicinal products used in pregnancy and lactation. Both pre-clinica Read More...		 , Spain
10/18/2007
Project Management: New Drug Product Development and Lifecycle Management
 Project Management: New Drug Product Development and Lifecycle Management
Course or Conference Sponsor: DIA Drug Information Association
Overview: At the end of this 2-day course, participants will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new Read More...		 PA, USA
10/18/2007
Harmonization of Risk Management Plans
 Harmonization of Risk Management Plans
Course or Conference Sponsor: DIA Drug Information Association
OVERVIEW This conference will teach you how to identify and organize essential components of an RMP vis-à-vis well-described risks, poorly understood risks, and certain pot Read More...		 PA, USA
10/18/2007
Medical Information & Communications
 Medical Information & Communications
Course or Conference Sponsor: DIA Drug Information Association
Overview: Through an interactive programme of presentations, discussion and case studies this meeting will share best practices in Medical Information and discuss current d Read More...		 , Spain
10/18/2007
Effective Project Management for Clinical Trials
 Effective Project Management for Clinical Trials
Course or Conference Sponsor: DIA Drug Information Association
Overview: As setting up and running clinical trials is now a complex and highly pressurised process, it is essential that clinical research proffessionals have the technica Read More...		 , Spain
10/18/2007
Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
 Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course provides comprehensive and up-to-date knowledge of assay validation for quality assurance and control of pharmaceuticals, biopharmaceuticals, and biologics. The co Read More...		 PA, USA
10/18/2007
Effective Quality Assurance Auditing for FDA Regulated Industries
 Effective Quality Assurance Auditing for FDA Regulated Industries
Course or Conference Sponsor: The Center for Professional Innovation & Education
This two-day course is designed for quality managers, auditors, regulatory/compliance professionals, production managers and top management interested in learning the value of Read More...		 PA, USA
10/22/2007
Design Control for Medial Device Professionals
 Design Control for Medial Device Professionals
Course or Conference Sponsor: The Center for Professional Innovation & Education
Upon completion of this course, attendees will have an understanding of the framework for Design Control and recommendations to effectively meet the requirements of Design Con Read More...		 PA, USA
10/22/2007
Regulatory II: The CTD/NDA Phase
 Regulatory II: The CTD/NDA Phase
Course or Conference Sponsor: DIA Drug Information Association
Overview: This course will offer insight into the regulatory background of the NDA, outline how to prepare an NDA in CTD format, and review post-approval activities. The co Read More...		 PA, USA
10/22/2007
The GLP Study Director
The GLP Study Director
Course or Conference Sponsor: CFPA The Center for Professional Advancement
The current regulatory environment imposes far reaching responsibilities on Study Directors and Principal Investigators in preclinical regulatory R&D. This course takes as ref Read More...		 NJ, USA
10/22/2007
Analytical Methods Validation for FDA Compliance
Analytical Methods Validation for FDA Compliance
Course or Conference Sponsor: CFPA The Center for Professional Advancement
One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis c Read More...		 , Ireland
10/22/2007
Critical Process Cleaning and Cleaning Validation
Critical Process Cleaning and Cleaning Validation
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course will provide a solid overview of the principles and technology of residue removal and residue measurement on product contact surfaces. It will address the latest i Read More...		 NJ, USA
10/29/2007
Conducting Effective Quality Audits
Conducting Effective Quality Audits
Course or Conference Sponsor: CFPA The Center for Professional Advancement
Government regulations have both explicit and implicit requirements for an internal audit function in the pharmaceutical and related industries. Auditing is a powerful managem Read More...		 NJ, USA
10/30/2007
ASTM 28th Symposium on Pesticide Formulations and Delivery Systems: Global Trends and Regulatory Drivers in the Crop Protection Industry
 ASTM 28th Symposium on Pesticide Formulations and Delivery Systems: Global Trends and Regulatory Drivers in the Crop Protection Industry
Course or Conference Sponsor: ASTM International
Fundamentals of formulations and applications technologies Innovative formulations for delivery of active ingredients Seed treatments and dressings Novel application techno Read More...		 FL, USA
10/31/2007
The Common Technical Document CTD: Recommended Format and Implementation of the ICH Common Technical Document for Marketing Application Submissions
 The Common Technical Document CTD: Recommended Format and Implementation of the ICH Common Technical Document for Marketing Application Submissions
Course or Conference Sponsor: The Center for Professional Innovation & Education
Upon completing this regulatory course, participants will have an understanding of how to employ the extensive recommended guidances - both ICH and regional (FDA and EMEA) - f Read More...		 PA, USA
11/01/2007
FDA Inspections of Clinical Data Systems
 FDA Inspections of Clinical Data Systems
Course or Conference Sponsor: The Center for Professional Innovation & Education
This regulatory course will provide the tools needed to prepare for a Clinical Data System inspection and to assess risk areas that need prioritization. Attendees will learn h Read More...		 PA, USA
11/01/2007
IQ, OQ, PQ
IQ, OQ, PQ
Course or Conference Sponsor: CFPA The Center for Professional Advancement
The installation/operational/performance qualification of equipment, systems, facilities, and processes for pharmaceutical sterile, oral solid dosage, finished and bulk manufa Read More...		 CA, USA
11/05/2007
Granulation, Tabletting and Capsule Technology
Granulation, Tabletting and Capsule Technology
Course or Conference Sponsor: CFPA The Center for Professional Advancement
The main aim of this course is to review the science relating to tabletted and encapsulated pharmaceutical products. The course begins with a consideration of raw material tes Read More...		 NJ, USA
11/05/2007
INDs, NDAs vs CTDs Global Regulations
INDs, NDAs vs CTDs Global Regulations
Course or Conference Sponsor: CFPA The Center for Professional Advancement
The content of this course is designed to present the intricate parts of INDs, NDAs, BLAs, ANDAs, SNDAs and CTDs. These regulatory submissions for drug and biologic products w Read More...		 , The Netherlands
11/05/2007
Pharmaceutical Quality Assurance and Control
Pharmaceutical Quality Assurance and Control
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course provides an understanding of the principles and practice of pharmaceutical quality assurance and control and of specific topics which have become important because Read More...		 , The Netherlands
11/05/2007
Early Stage Clinical Development
Early Stage Clinical Development
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This two-day course will give a comprehensive overview of the regulatory requirements, design, conduct and analysis of FIM (first in man) studies of new drugs, biologics and m Read More...		 , The Netherlands
11/05/2007
Preparing the CMC Section for NDAs/INDs
 Preparing the CMC Section for NDAs/INDs
Course or Conference Sponsor: The Center for Professional Innovation & Education
This regulatory course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the Common Technical Document CTD, detailed Read More...		 California, USA
11/05/2007
Overview of Drug Development
 Overview of Drug Development
Course or Conference Sponsor: DIA Drug Information Association
Overview: This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regula Read More...		 PA, USA
11/05/2007
Regulatory Affairs: Part I : The IND Phase, Part II: The CTD/NDA Phase
 Regulatory Affairs: Part I : The IND Phase, Part II: The CTD/NDA Phase
Course or Conference Sponsor: DIA Drug Information Association
Overview: This course combines the two three-day courses into one extended four-day offering. It describes the regulatory background of the IND and NDA and provides an over Read More...		 PA, USA
11/05/2007
European Regulatory Affairs: An In-Depth Review of Registration Procedures in the European Union
 European Regulatory Affairs: An In-Depth Review of Registration Procedures in the European Union
Course or Conference Sponsor: DIA Drug Information Association
Overview: This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union Read More...		 DC, USA
11/05/2007
European Regulatory Affairs: An In-Depth Review of Registration Procedures in the European Union
 European Regulatory Affairs: An In-Depth Review of Registration Procedures in the European Union
Course or Conference Sponsor: Drug Information Association (DIA)
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 19 Read More...		 DC, USA
11/05/2007
Overview of Drug Development Training Course
 Overview of Drug Development Training Course
Course or Conference Sponsor: Drug Information Association (DIA)
This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, Read More...		 PA, USA
11/05/2007
Regulatory Affairs: Part I : The IND Phase & Part II: The CTD/NDA Phase
 Regulatory Affairs: Part I : The IND Phase & Part II: The CTD/NDA Phase
Course or Conference Sponsor: Drug Information Association (DIA)
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an over Read More...		 PA, USA
11/07/2007
Features and Benefits of FDA Data Exchange Standard Initiatives; An Online Course 10:00AM - 11:30AM
 Features and Benefits of FDA Data Exchange Standard Initiatives; An Online Course 10:00AM - 11:30AM
Course or Conference Sponsor: DIA Drug Information Association
Overview: Special Update on FDA Data Exchange Standards This webinar will provide insight into the data exchange standard, an update on the progress of the standard deve Read More...		 ,
11/08/2007
Design Control for Medical Device Professionals
 Design Control for Medical Device Professionals
Course or Conference Sponsor: The Center for Professional Innovation & Education
Upon completion of this course, attendees will have an understanding of the framework for Design Control and recommendations to effectively meet the requirements of Design Con Read More...		 , Ireland
11/12/2007
Biopharmaceutical Process Systems
Biopharmaceutical Process Systems
Course or Conference Sponsor: CFPA The Center for Professional Advancement
All biopharmaceutical products are manufactured in a regulated environment to ensure the quality and safety of these substances. Biopharmaceutical facilities are licensed to m Read More...		 , The Netherlands
11/12/2007
Applied cGMPs for Pharmaceutical and Allied Industries
Applied cGMPs for Pharmaceutical and Allied Industries
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course takes you through Current Good Manufacturing Practice (cGMP) in the pharmaceutical and allied industries. Topics covered include legal requirement for cGMP in the Read More...		 FL, USA
11/12/2007
Developing Standard Operating Procedures (SOPs)
 Developing Standard Operating Procedures (SOPs)
Course or Conference Sponsor: DIA Drug Information Association
Overview: One of the best ways to ensure that organizations meet their business and regulatory obligations is to follow standard operating procedures (SOPs). Standard opera Read More...		 FL, USA
11/14/2007
Medical Device Regulatory Compliance
 Medical Device Regulatory Compliance
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This continually updated course covers current FDA regulatory compliance issues with respect to developing, manufacturing, and marketing medical devices. It includes an overvi Read More...		 NJ, USA
11/14/2007
Skin Product Development
 Skin Product Development
Course or Conference Sponsor: The Center for Professional Innovation & Education
The topics considered include designation of product goals and formulation design with reference to product performance, factors affecting delivery of actives to the skin, del Read More...		 PA, USA
11/15/2007
Global Animal Health Conference
 Global Animal Health Conference
Course or Conference Sponsor: DIA Drug Information Association
Overview: This conference will provide a unique opportunity to participate in the first global conference on animal health and veterinary medicines for some years, where wo Read More...		 , UK
11/15/2007
DIA Workshop on Paediatric Oncology
 DIA Workshop on Paediatric Oncology
Course or Conference Sponsor: DIA Drug Information Association
Overview: Today's therapeutic standard in paediatric oncology: Patients are included into clinical trials conducted by international collaborative groups. These thrive to d Read More...		 , UK
11/18/2007
DIA, ICRI, AND BCI 2nd Annual Conference on DRUG DISCOVERY AND CLINICAL DEVELOPMENT IN INDIA Scientific Platform for global Regulatory Landscape through Biologics and Medical Devices
 DIA, ICRI, AND BCI 2nd Annual Conference on DRUG DISCOVERY AND CLINICAL DEVELOPMENT IN INDIA Scientific Platform for global Regulatory Landscape through Biologics and Medical Devices
Course or Conference Sponsor: DIA Drug Information Association
Overview: Jointly organized by the Drug Information Association (DIA) and Institute of Clinical Research (India), ICRI, with collaborative sponsorship from Biomedical Consu Read More...		 , India
11/21/2007
Biomarkers in the Drug Development Process
 Biomarkers in the Drug Development Process
Course or Conference Sponsor: DIA Drug Information Association
Overview: At this workshop, systems biology, (toxico)genomic, functional genomic, proteomic and metabonomic data related to biomarker development will be presented and disc Read More...		 , The Netherlands
11/21/2007
 An All-Encompassing Look at Laboratory Information Management Systems (LIMS)
Course or Conference Sponsor: BenAstrum Inc.
Speaker: Bernice Russell Bond Discussion points to be covered include: Extensive LIMS overview In-depth look at the measures required to be in place for regulatory comp Read More...		 QC, Canada
11/21/2007
Auditing and Inspecting Preclinical Research for GLP Compliance
Auditing and Inspecting Preclinical Research for GLP Compliance
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course will explore the activities of a Quality Assurance department when auditing studies for GLP compliance. All aspects of QA work will be discussed including; the pre Read More...		 , The Netherlands
11/27/2007
Overview of FDA Regulatory Compliance for Medical Devices
 Overview of FDA Regulatory Compliance for Medical Devices
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course discusses the Agency's regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities. It also Read More...		 California, USA
11/28/2007
Critical Process Cleaning and Cleaning Validation
Critical Process Cleaning and Cleaning Validation
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course will provide a solid overview of the principles and technology of residue removal and residue measurement on product contact surfaces. It will address the latest i Read More...		 , Ireland
11/29/2007
IQ, OQ, PQ
 IQ, OQ, PQ
Course or Conference Sponsor: CFPA The Center for Professional Advancement
The installation/operational/performance qualification of equipment, systems, facilities, and processes for pharmaceutical sterile, oral solid dosage, finished and bulk manufa Read More...		 , The Netherlands
11/29/2007
Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
 Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
Course or Conference Sponsor: The Center for Professional Innovation & Education
Upon completion of this course you will have a clear understanding of regulatory agency expectations and will have gained the background knowledge necessary to effectively pla Read More...		 California, USA
11/29/2007
European Filing and Registration Procedures
 European Filing and Registration Procedures
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course specifically focuses on agencies that control the regulatory process. The course will cover topics relating to pre-clinical and clinical requirements, as well as, Read More...		 PA, USA
11/29/2007
Best Practices for an Effective Cleaning Validation Program
 Best Practices for an Effective Cleaning Validation Program
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity pla Read More...		 PA, USA
12/02/2007
8th European Electronic Document Management Conference
 8th European Electronic Document Management Conference
Course or Conference Sponsor: DIA Drug Information Association
Overview: The need and opportunity for managing records and regulatory submissions electronically, has never been so great in the pharmaceutical industry. This poses great Read More...		 , Czech Republic
12/03/2007
2nd Cardiac Safety Conference
 2nd Cardiac Safety Conference
Course or Conference Sponsor: DIA Drug Information Association
Overview: ICH E14 QT Guidance were finalised (step 4) in May 2005. However, implementation of the new guidance (step 5) seems to have taken a different pace in different IC Read More...		 , Czech Republic
12/03/2007
Generic Drug Approvals - Preparing an ANDA For First Cycle Approval
 Generic Drug Approvals - Preparing an ANDA For First Cycle Approval
Course or Conference Sponsor: The Center for Professional Innovation & Education
The course covers regulatory expectations regarding the format and content as described in FDA regulations and guidelines. The course focuses on the preparation of a paper-bas Read More...		 PA, USA
12/03/2007
ICH-Q7
ICH-Q7
Course or Conference Sponsor: CFPA The Center for Professional Advancement
It is essential that API production facilities operating under local regulatory authorities in different regions consistently produce the same API that meets the quality attri Read More...		 , The Netherlands
12/03/2007
Vendor and Contract Supplier Qualification
Vendor and Contract Supplier Qualification
Course or Conference Sponsor: CFPA The Center for Professional Advancement
From both a regulatory and business perspective, firms should partner with their suppliers (both vendors and contract suppliers) to assure that they receive materials and serv Read More...		 NJ, USA
12/03/2007
Biopharmaceutical Process Systems
 Biopharmaceutical Process Systems
Course or Conference Sponsor: CFPA The Center for Professional Advancement
All biopharmaceutical products are manufactured in a regulated environment to ensure the quality and safety of these substances. Biopharmaceutical facilities are licensed to m Read More...		 CA, USA
12/05/2007
Pharmaceutical Technology Transfer
Pharmaceutical Technology Transfer
Course or Conference Sponsor: CFPA The Center for Professional Advancement
This course will provide a basic understanding of the technology transfer of analytical methods, quality control standards, packaging components/operations and various pharmac Read More...		 , The Netherlands
12/05/2007
Software Development for Medical Device Professionals
 Software Development for Medical Device Professionals
Course or Conference Sponsor: The Center for Professional Innovation & Education
This continually updated course covers current FDA regulatory compliance with respect to developing medical device software. A focus will be placed on both the regulation and Read More...		 PA, USA
12/05/2007
Laboratory Safety
 Laboratory Safety
Course or Conference Sponsor: American Chemical Society
Learn best practices to minimize personal injury, health impairment, property loss, fines, and liability in your laboratory. This course gives you an overview of the practical Read More...		 CA, USA
12/06/2007
Future Regulatory Challenges in the Quality Area
 Future Regulatory Challenges in the Quality Area
Course or Conference Sponsor: DIA Drug Information Association
Overview: The new ICH Guidelines Q8, Q9 and Q10 have introduced new concepts of manufacturing of drug products quality-by-design, design space and quality systems. Thes Read More...		 , The Netherlands
12/06/2007
6th European Validation Workshop
 6th European Validation Workshop
Course or Conference Sponsor: DIA Drug Information Association
Overview: This is the sixth DIA Validation Meeting in Europe and will focus on quality and risk management. The meeting will address both the regulatory and practical aspec Read More...		 , The Netherlands
12/06/2007
Introduction to Effective Medical Writing
 Introduction to Effective Medical Writing
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course is valuable to those who write or review documentation in support of clinical trials and regulatory submissions. Well written submission documentation can decre Read More...		 , Ireland
12/06/2007
Drug Master Files - Understanding and Meeting Your Regulatory and Processing Responsibilities
 Drug Master Files - Understanding and Meeting Your Regulatory and Processing Responsibilities
Course or Conference Sponsor: The Center for Professional Innovation & Education
Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoid Read More...		 PA, USA
12/10/2007
Laboratory Analysis in Clinical Trials
 Laboratory Analysis in Clinical Trials
Course or Conference Sponsor: CFPA The Center for Professional Advancement
Good Clinical Practices (GCP) does not provide detailed requirements regarding the conduct of laboratory activities in clinical trials. Therefore, laboratories have applied th Read More...		 , The Netherlands
12/11/2007
EudraVigilance: Medicinal Product Dictionary
 EudraVigilance: Medicinal Product Dictionary
Course or Conference Sponsor: DIA Drug Information Association
Overview: This EVMPD course is addressing specifically all aspects related to the regulatory background, the definitions and procedures and the technical specifications for Read More...		 , UK
12/12/2007
The GLP Study Director
 The GLP Study Director
Course or Conference Sponsor: CFPA The Center for Professional Advancement
The current regulatory environment imposes far reaching responsibilities on Study Directors and Principal Investigators in preclinical regulatory R&D. This course takes as ref Read More...		 , Amsterdam
12/13/2007
Adverse Drug Events - Understanding and Reporting Requirements
 Adverse Drug Events - Understanding and Reporting Requirements
Course or Conference Sponsor: The Center for Professional Innovation & Education
This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and report Read More...		 PA, USA
12/13/2007
Creating High-performance Medical Science Liaison Teams
 Creating High-performance Medical Science Liaison Teams
Course or Conference Sponsor: DIA Drug Information Association
Overview: Special West Coast Forum on the Evolution of Medical Science Liaison Teams This one-day conference will provide a neutral forum for individuals from pharmaceut Read More...		 CA, USA
12/13/2007
Clinical and Laboratory Genomic and Genetic Standards
 Clinical and Laboratory Genomic and Genetic Standards
Course or Conference Sponsor: DIA Drug Information Association
Overview: This meeting is intended to serve as a forum for discussion of reference standards and guidelines as used in microarray-based assays to manage quality control, an Read More...		 MD, USA
12/13/2007
 Developing Stability-Indicating Methods for Pharmaceutical Products-Benastrum Live Webinar
Course or Conference Sponsor: BenAstrum Inc.
Speaker: Kim Huynh-Ba Discussion points to be covered include: Impact of analytical testing in the drug development process cGMP requirements for analytical test met Read More...		 QC, Canada
8 September 2007
Institute of Pharmaceutical Management
 Institute of Pharmaceutical Management
Course or Conference Sponsor:
A Bird's eye-view Institute of Pharmaceutical Management (IPM) is a pioneering institution for pharmaceutical training in India in Pharma Quality Management, Drug Regula Read More...		 Maharashtra, India
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International Regulatory News

UKAS Assessment Programme for Accreditation for Certification of Green Deal Advisors and Installers
2011-12-12 00:00:00
The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to ... 

Trident catheter valve - Model Number: 380851
2011-12-12 00:00:00
The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled. The Trident Catheter Valve is used for connecting a urinary cath... 

TGA reforms: a blueprint for TGA's future
2011-12-08 00:00:00
Government to improve regulation of therapeutic goods media release, The Hon Catherine King MP 8 December 2011 The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undert... 

Respirtek ISO 17025 Business Management Improvements
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

Respirtek, Inc. ISO 17025 Accreditation Announcement
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update
2011-11-11 00:00:00
The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, wher... 

ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE
2011-11-08 00:00:00
A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving... 

Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry
2011-11-01 00:00:00
Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of ... 

FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation
2011-10-26 00:00:00
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgeto... 


2011-10-26 00:00:00
FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tabl... 

FDA approves Onfi to treat severe type of seizures
2011-10-26 00:00:00
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended t... 

Illinois warehouse Prevents unsafe food distribution from rodent-infested facility
2011-10-19 00:00:00
FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warr... 

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