New Member Service: the Guide to Drug Regulatory Affairs/ Book on Demand from Editio Cantor Verlag now available at a discount

Obtaining drug marketing authorisation in the EU is a complex process, necessitating a broad range of knowledge in various areas of specialisation that requires
Regulatory Affairs Managers to be a pharmacist, lawyer, quality manager and project manager in one.

You can use various sources to draw up marketing authorisation applications, but if you are not sure what exactly you are looking for, it is easy to get lost in
the sheer abundance of information and lose valuable time.The Guide to Drug Regulatory Affairs eases you through the necessary procedures, comments on EU and EMEA
documents and helps you draw up your application.

The guide is available in a print edition as well as an online version for access to over 1,000 regulatory documents. Written and compiled by respected experts from government agencies, institutions and companies for both newcomers and professionals in the regulatory scene, the Guide is a reference work on the organisational, legal and CTD aspects of applying for marketing authorisation.

There are 6 sections:

Part A: application procedures, the legal framework and the requirements that need to be taken into consideration in preparing documents.
Part B: practical advice on the actual work of making an application.
Part C: how to obtain marketing authorization for special drug products, including blood products, orphan drugs and traditional herbal medicines.
Parts D and E: special drug products for children and the requirements and possibilities of electronic marketing authorisation.
Part F: a collection of application forms and relevant websites.

Definitions and explanations of over 300 technical terms and abbreviations are also included in both the print and online edition.

The contents of the online version are regularly updated and amended by the authors, plus an email service alerts users to developments.

Advantages of the print-on-demand version

In line with legislational developments and changes, the Guide is regularly updated and amended by its editors and authors with the help of a modern content management system.

The book is printed when ordered (in either hardcover or paperback form) and thus reflects the contents of the online version of the Guide at the time of ordering.

Who should buy the Guide?

  • Employees, executives and directors in the pharmaceutical and API industry
  • Legal advisers and attorneys
  • Employees and heads of regulatory authorities
  • Consultants
  • Quality assurance professionals
  • Drug regulatory trainees

Rates for TOPRA Members:

  • First year online subscription: €750 (Normal price: €1250)
  • Book Print-on-demand (The latest version of the database printed on the day you order): €380 (Normal price €430)

For more information or to order to Guide, please visit www.drugregulatoryaffairs.eu