EMEA Annual legislation update

Brochure & booking form

Aims of the Conference

This conference follows on from the success of two earlier joint meetings between TOPRA and the EMEA and its aim is to provide a practical insight into the workings of the EMEA. The aim is to bring together regulatory personnel from both the national agencies and industry in order to share regulatory knowledge, specifically when coordinated via the EMEA. You will hear not only about the existing processes such as the centralized procedure and scientific advice but also how the new paediatric committee has performed over its first year, the impact of the new rules on pharmacovigilance, how the Advanced Therapy committee will be organized and Transparency – how open are we with each other?
The last session of the conference will provide an open forum for discussing emerging topics. An aim of this meeting is also to facilitate networking and there will be ample opportunity to meet many regulatory personnel from agencies and industry and particularly from the EMEA during the refreshment break, lunches and at the evening drinks reception.

Who should attend

This conference will cover all the major areas of medicines legislation covered by the European Medicines Agency. If you are working at a Europe wide level then this meeting is a must for all levels of regulatory personnel. It will provide you with practical advice on the working of the EMEA within the European regulatory network. As well as speakers from the EMEA there will also be representatives of
the national agencies and the European Commission plus Industry representatives to offer their experiences.

Conference programme includes:

• New Regulatory Legislation
• Scientific Advice
• Paediatrics
• Advanced Therapies
• EMEA processes and procedures
• Pharmacovigilance
• Transparency
• Open Question Session

Speakers Include

• Daniel Brasseur, chair of Paediatric Committe (PDCO), EMEA
• Axel Breitstadt, MSD (Europe) Inc, Belgium
• Melanie Carr, EMEA
• Patrick Celis, EMEA
• Ali Harrison AstraZeneca, UK
• Martin Harvey Alchurch, EMEA
• Ian Hudson, MHRA, UK
• Alan Hunter, TOPRA President
• David Laurie, Novartis, Switzerland
• Patrick LeCourtois, EMEA
• Marisa Papaluca, EMEA
• John Purves, EMEA
• June Raine, chair CHMP Pharmacovigilance working party and MHRA, UK
• Vincenzo Salvatore, EMEA
• Christian Schneider, PEI, Germany
• Tomas Salmonson, Vice chair CHMP, EMEA and MPA, Sweden
• Thomas Severin, Novartis, Switzerland
• Noel Wathion, EMEA
• Anne Wigmore, GlaxoSmithKline, UK

Other speakers from National Competent Authorities, EMEA, European Commission, Industry and other health care related bodies have been invited.

Lifelong Learning (LLL):
This meeting contributes 12 hours of training to your LLL (sometimes known as Continuing Professional Development) and will enhance your Regulatory Skills relevant in the areas of human and veterinary medicines.