Guide to Drug Regulatory Affairs / Book

What is the ’Guide’ about?
This is the first comprehensive overview of the legal and regulatory
framework for marketing authorisation applications in Europe, including
Switzerland. It gives extensive and valuable advice on how to compile
a marketing authorisation according to the CTD format (Modules 1 – 5
CTD).

Why has the ’Guide’ been developed?
The ’Guide’ has been developed to penetrate the ’regulatory jungle’ and make related work much easier and more efficient. With both a printed and a regularly updated online edition, the ‘Guide’ is a multi-media platform designed to support the different needs of its many users.

The ’Guide’ is subdivided into four major parts

Part A: This provides detailed information about different procedures for drug approval, and relevant legislation and requirements that have to be considered when submitting an application for marketing authorisation. Judicial decisions from pertinent European courts are also highlighted.

Part B: This gives detailed practical advice on how to prepare an application for marketing authorisation and also the accompanying documents which demonstrate quality, safety and efficacy. In addition, aspects of maintaining the marketing authorisation are discussed, covering applications for variations to a marketing authorisation, extension applications and renewal applications. Regulatory compliance issues are considered, and the requirements for IMPDs (Investigational Medicinal Product Dossiers) are included. Marketing authorisation procedures and the regional part of a Swiss marketing authorisation application are also considered.

Part C: This describes the main provisions relevant to biopharmaceuticals, plant-based traditional medicinal products, blood, blood products and orphan drugs.

Part D: This includes much additional helpful information: an index of abbreviations, an index of terms and definitions, literature, links etc.

Available as a print or online edition, the ‘Guide’ is a multi-media resource
designed to support the different needs of its users.

Contents – Print and Online Edition
The print edition with more than 1100 pages is primarily intended as an invaluable
reference-book.

The key benefits of the constantly updated, user friendly and easily navigated
online edition include:

Multiple search options, such as full-text, chapters, terms and keywords
Constant updates and amendments
Comments and interpretation of EMEA and EU news and documents
Instant access to all relevant official documents
Direct link to EU and EFTA authorities
Permanent link check to nearly 700 links mentioned in the Guide
Discussion Forum
Regular Newsletter
Link to upcoming events including conferences and education courses in the field of Drug Regulatory Affairs
Job Market

Target groups:
- Employees, Executives and Directors of Pharmaceutical Companies and the
API Industry (API Active Pharmaceutical Ingredients)
- Legal Advisers and Attorneys
- Employees and Heads of Regulatory Authorities
- Consultants
- Professionals in Quality Assurance
- Training in Regulatory Affairs