Innovation Forum
September, 29-30, 2008 – London Marriott Regents Park, UK
The conference will involve all stakeholders including policy makers, industry and academia. The conference is organised over two days. The first day will address the progress with the implementation of the Innovative Medicines Initiative and the EMEA initiatives to support innovation including the qualification of biomarker and new methodologies. The second day will focus on the practical aspects to implement the Regulation on Advanced Therapy.
More information >> Download the flyer >>
Conference Co-Chairs
Georgette Lalis
Director of the Directorate for Consumer Goods, European Commission,
DG Enterprise and Industry, EU
Thomas Lönngren
Executive Director, EMEA, EU
Programme Co-Chairs
Iman Barilero
Divisional Director Regulatory Development Strategy, H. Lundbeck A/S, Denmark
Patrick Le Courtois
Head of Unit Pre-Authorisation Evaluation of Medicines for Human Use, EMEA, EU
Programme Committee
Day 1:
Eric Abadie, Chairman, CHMP, EMEA, EU, General Directorate, AFSSAPS, France
Hans-Georg Eichler, Senior Medical Officer, EMEA, EU
Bruno Flamion, Chair, Scientific Advice Working Party, EMEA, University of Namur, Belgium
Kerstin Franzen, Senior Director Worldwide Regulatory Policy & Intelligence, Pfizer AB,
Sweden
Hilary Malone, Senior Vice President and Head of Global Regulatory Affairs, Wyeth, USA,
EFPIA RDG
Marisa Papaluca-Amati, Deputy Head of Sector, Safety & Efficacy of Medicines, EMEA, EU
Spiros Vamvakas, Acting Deputy Head of Sector, Scientific Advice & Orphan Drugs, EMEA, EU
Day 2:
Eric Abadie, Chairman, CHMP, EMEA, EU, General Directorate, AFSSAPS, France
Arnd Hoeveler, Head of Unit Biotechnology for Health, European Commission - Research
Directorate General, EU
Wills Hughes-Wilson, Director, Health Policy Europe, Genzyme, Belgium, EuropaBio, EBE and
Eucomed
Detlef Niese, Head, External Affairs, Clinical Development & Medical Affairs, Novartis Pharma
AG, Switzerland, EuropaBio, EBE and Eucomed
Dario Pirovano, Consultant, Regulatory & Technical Affairs, Belgium, EuropaBio, EBE and
Eucomed
John Purves, Head of Sector, Quality of Medicines, EMEA EU
Irene Sacristán Sánchez, Deputy Head of Unit - Pharmaceuticals DG Enterprise and Industry,
European Commission, EU
Martin Terberger, Head of Pharmaceuticals Unit, DG Enterprise & Industry,
European Commission, EU
Who Should Attend?
• Regulatory Representatives
• Industry Representatives
• Academia Representatives
• Patient Groups
Learning Objectives:
- Provide an update on the initiatives in Europe to support innovation in research and development
- Share the FDA experience with the implementation of the Critical Path Initiative and coordination with the EU initiatives
- Provide a platform to discuss the implementation of the European Parliament and Council Regulation on Advanced Therapy and the EMEA draft technical guidelines
Day 1: Update on Initiatives to Support Innovation in Europe
- Innovation in Europe – What Are The Challenges of The Future?
- Innovative Medicines – Implementation
- Qualification of Biomarkers and Novel Methodologies
- Role of EMEA in Relation to Innovation – Think Tank Report Implementation
Day 2: Advanced Therapy - Implementation of the New Regulation
- EU Commission and EMEA Implementation
- EU Commission and EMEA Implementing Technical Requirements
- Risk Management, Pharmacovigilance and Traceability
- GMP and GCP Issues
Event Code: 08108
For further information, please contact the DIA Europe Customer Services Team on +41 61 225 51 51, Monday-Friday from 08:00-17:00 CET.
Or email: diaeurope@diaeurope.org
Your DIA Europe Events Team
_______________________
DIA Europe
Elisabethenanlage 25
Postfach
CH-4002 Basel
Switzerland
Tel: +41 61 225 51 51
Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
To learn more about DIA conferences, workshops and training courses in Europe and the Middle East, please visit www.diahome.org