The 6th Annual TOPRA Symposium

European Regulatory Affairs in a Global Environment

The largest purely Regulatory Affairs event of the year and now in its 6th year. An important element of previous symposia in Paris, Berlin, Amsterdam, Copenhagen and Budapest has been the close working relationship with the local regulatory agency and this year we welcome the input of the Medical Products Agency, Sweden. This is the key regulatory event of the year to meet fellow regulatory agency and industry colleagues.

TOPRA in Stockholm: Symposium Preview

Confirmed Speakers

• Masatomi Akana, Director Global Regulatory, Eisai, UK
• Lennart Åkerblom, Head of Section, MPA, Sweden and member of CAT
• Christina Åkerman, Director General, MPA, Sweden
• Caroline Baillif, Senior Manager RA, AMGEN, UK*
• Paolo Biffignandi, CEO, VI.REL Pharma S.a.s, Italy*
• Thony Björk, President PGEU (Pharmaceutical Group of the European Union), Vice President, Apoteket AB, International Affairs, Sweden
• Hilde Boone, Scientific Administrator, EMEA
• Gert Bos, Head of Clinical and Regulatory Affairs, BSI, UK
• Daniel Brasseur, Chair of PDCO and Belgian Federal Agency for Medicines, Belgium
• Patrick Celis, Scientific Administrator, EMEA
• Vincenzo Costigliola, President, European Medical Association, Belgium
• Sarah Daniels, Senior Partner, TranScrip Partners LLP, UK
• Wilfried Dalemans, Vice President, Regulatory Affairs and Corporate Quality, Tigenix, Belgium
• Kerstin Franzén, Sr Director Worldwide Regulatory Policy & Intelligence, Pfizer, Sweden
• Vera Franzén, RA Director, SentoClone AB, Sweden*
• Åsa Holmgren, Vice President RA, Orexo AB, Sweden*
• Alan Hunter, TOPRA President 2008/2009
• Brenton E James, EU RA Consultant, UK*
• David Jefferys, Senior Vice President Global Regulatory, Eisai, UK
• Margareth Jorvid, Senior Partner, LSM Group, Sweden**
• Don Kennard, Vice President of Regulatory Affairs and Quality, Halozyme Therapeutics, USA
• Hartmut Krafft, Head, Section Clinical Trials, Paul-Ehrlich-Institut, Germany and chair CTFG
• Thomas Lönngren, Executive Director, EMEA
• Murray Lumpkin, Principal Associate Commissioner, FDA, USA
• Carrol Marcus, Vice President, PAREXEL Consulting, UK
• Jean Marimbert, Directeur General, Afssaps, France
• Patrizia Nestby, Senior Consultant, PAREXEL Consulting, UK*
• Alastair Nixon, Director, Submission Publishing, GSK, UK
• Beatrice Oberlé-Rolle, Head of RA, NobelBiocare, Switzerland*
• Ann O’Connor, Director of Human Products Authorisation and Registration, Irish Medicines Board (IMB), Ireland
• Jan Petracek, Risk Management Team, EMEA
• Lennart Philipson, Director Medical Devices, MPA, Sweden
• Ana Rodriguez, Scientific Administrator, Inspection Sector, EMEA
• Irene Sacristán Sánchez, Deputy Head Unit F2 Pharmaceuticals, European Commission
• Christer Safholm, VP Pre-Clinical Safety Assessment, AstraZeneca, UK
• Agnes Saint Raymond, Head of Sector, EMEA
• Tomas Salmonson, Vice Chair CHMP, MPA, Sweden
• Christian Schneider, Chair of CAT, Paul-Ehrlich-Institut, Germany
• Norman Schmuff, Branch Chief ONDQA, CDER, FDA, USA
• Annelie Skagerlind, Director RA, Medivir, Sweden
• Zena Smith, Regulatory CMC Manager, Pfizer, UK
• Steffen Thirstrup, Chief Medical Officer, Lægemiddelstyrelsen (Danish Medicines Agency), Denmark
• Markku Toivonen, Scientific Director, NDA Advisory Board, NDA Regulatory Science Ltd, UK
• Hans-Georg Wagner, Head of Communications and Networking, EMEA
• Lynda Wight, Executive Director, TOPRA

From SPIN groups:
TOPRA North America – Susanne Dorn, Halozyme Therapeutics, USA*
eRA – Peter James, Dao-eRA Ltd, UK*
CMC – Aine Kane, Pfizer Ltd, UK*

*Working Party

** Working Party Chair

Other Working Party members include:

• Ursula Forner, MPA, Sweden
• Henrik Holst, (Veterinary), MPA, Sweden
• Tony Humphreys, EMEA
• Lennart Philipson, (Medical Devices), MPA, Sweden
• Helene Thybo, LEO Pharma A/S, Denmark
• Sharon Pichon, AAPS, USA

From SPIN groups:
Medical Devices – Neil Adams, BSI Group, UK
Veterinary – Ray Harding, Cyton Biosciences, UK
Speakers may be subject to change

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

Programme includes:

• Best practice on the use of Marketing Authorisation Procedures in the European Union
• Advanced Therapy Medicinal Products /CAT
• Combination Products (drug-device)
• Pharmacovigilance
• Paediatrics
• Pharmaceutical Clinical Trials in the Global Environment
• Globalisation
• European Union - latest news

Parallel break out sessions covering:

• Electronic Regulatory Affairs
• Regulatory Careers
• TOPRA North America group: updates from FDA and industry
• TOPRA CMC group: The new EU variations regulation and guidelines

Read about last year's TOPRA Annual Symposium 2008