News from the 4^th TOPRA Annual Symposium

Leading regulators launch TOPRA Annual Symposium programme

The Fourth TOPRA Annual Symposium brought together the leading experts in regulatory affairs to discuss the latest issues and developments in the field. The opening session of the Symposium will discuss Challenges through 2010 as seen by some of the most influential industry and agency figures.

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Hristov demonstrates determination and progress at Bulgarian Agency

Addressing the largest ever TOPRA Annual Symposium in Copenhagen, Dr. Emil Hristov, Director of the Bulgarian Drug Agency, set out in detail his Agency’s work to become a member of the European Regulatory Network as a new member state since January. His message to delegates was clear—the BDA has made tremendous progress and will, in good time, become a first-rate regulatory agency in Europe.

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Today representatives from the European Commission and the Pharmaceutical industry at the 4th TOPRA Annual Symposium discussed the progress of the Pharmaceutical Forum; its successes and the challenges which still lie ahead.

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European Regulatory Affairs Network and Industry agree on need for better regulation agenda

‘Getting rid of the paper’ was one topic discussed by Lars Olsen, Executive Vice President – Research and Development at Leo Pharma in the Opening Session of the TOPRA Annual Symposium in Copenhagen. His point was simple—regulators and legislators must take steps to reduce the burden on industry using innovations such as electronic Common Technical Document (eCTD).

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TOPRA announces world-class line-up for joint conference with EMEA

The Organisation for Professionals in Regulatory Affairs (TOPRA) has announced the presenters for its forthcoming conference on New Medicines Legislation.  The joint event, held in conjunction with the European Medicines Agency, will examine a variety of key topics for regulatory affairs professionals, heads of strategy, legal departments, and other senior management across the pharmaceutical industry.

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CRED 2008 Programme launched

The CRED Prospectus 2008 has been published and the programme, once again, include a wide variety of topics. Life Cycle Management, Pharmaceutical Dossier – CMC, Medical Devices, SmPC, PIL and labelling, Biotechnology and European Regulatory Procedures are all covered.

For more information on the CRED events please click here.

Autumn Introductory Course and CRED Course on Clinical Development great success

Both the 13^th Autumn Introductory Course and the two-day CRED Course on Clinical Development were exceptionally successful, with both being over subscribed. The Autumn Introductory Course was held in Prague, Czech Republic for the first time and this move was very well received.

The CRED Course, held in London, saw speakers from Parexel, Norgene Ltd, and Lilly inform delegates about the important topic of Early to Late Stage Clinical Development, including Clinical Pharmacokinetics, Clinical Pharmacodynamics and Safety.

It was 30 years ago this year – 30^th Spring Introductory Course taking place in 2008

In 2008 TOPRA will once again organise the immensely popular Spring Introductory Course, the 30^th time TOPRA is doing this. The course, widely accepted by both Industry and Regulatory Agencies as the most comprehensive of its kind, provides new Regulatory Affairs professionals with a good understanding of the different functions involved in the product development process and their inter-dependencies.

In addition, a good legislative overview will be gained, with case studies providing delegates with practical experience of working in a project team on a variety of regulatory challenges.

To download a brochure, click here

Date	Venue	Module
27-29 Nov 2007	Prague	Module 2	Regulatory Strategy for a New Active Substance: Preclinical development
29-31 Jan 2008	Park Plaza Hotel, Cardiff	Module 3	Regulatory requirements for a New Active substance: Chemistry & Pharmacy
1-3 Apr 2008	Magdalene College, Cambridge	Module 4	Regulatory Strategy for a New Active Substance: Global Clinical Development
10-12 Jun 2008	Marriott Worsley Park Hotel, Manchester	Module 12	Medical Device Regulatory Affairs