Keynote Programme
At our biennial Congress, we offer Keynote sessions in addition to the specialised seminars. This provides an opportunity for pharmaceutical manufacturing science and biotechnology professionals to hear about wider issues and emerging global trends and practices.
This year we are splitting the Keynotes across two themed half-days. On Tuesday afternoon, we look at The Keys to Business Success, featuring the growing importance of science-based development. What will our future look like? What can we learn from other industries? There is also a session for suppliers to the biopharmaceutical industry – what you must do to keep our business.
The Regulatory Forum on Wednesday 24 March (Keynote Session 2) will provide an opportunity to hear from senior leaders of regulatory agencies from Europe, United States and the World Health Organisation. The regulators will provide a brief update on key development in the regulatory area. A major part of the session will be interactive. This will allow attendees to put their questions on Quality-related topics to a distinguished panel of leaders from regulatory agencies in Europe, the USFDA and WHO. The regulatory agency leaders from both review and inspectorate divisions will participate.
Attendees who do not wish to speak during the session may also send questions until 12 March to the following e-mail address (nina.todorova@associationhq.com).
| Keynote Session 1 Tuesday 23 March - afternoon Session Chaired by: Alan MacNeice, Chairman ISPE 14.15 – 14.55 R&D 2020: A decade of opportunity and change Ingrid Maes, PriceWaterhouseCoopers (Belgium) This presentation highlights the main conclusions from the recent PriceWaterhouseCoopers’ “Pharma 2020 The vision” report and its implications on R&D and manufacturing. How to get there and which technologies are enablers to achieve excellence now and in the future. 14.55 – 15.45 How to Survive Until 2020 and Beyond Leo Hammendorp, Siemens (Germany) This presentation will give a more practical look on what technology is available and required to keep up with the trend. Some scenarios of implementation strategies and a look at other sectors where similar requirements are applicable. 15.45 – 16.15 Coffee Break and Exhibition 16.15 – 17.00 Winning Customers Through Science-Based Product Development Filippo Ferrari, Parmalat (Italy) • How product development can provide a competitive advantage • Use of science and risk-based methodologies within the food and beverage industry • Examples of science-based product development within Parmalat• What the pharmaceutical industry can learn from the food and beverage industry 17.00 – 17.45 How To Be My Favourite Supplier Simon Shelley, GSK (UK) • Experiences of purchasing materials and equipment for pharmaceuticals manufacturing • What can go wrong • What must suppliers do to win my business? |
Keynote Session 2 Wednesday 24 March - morning Session Chaired by: Alan MacNeice, Chairman ISPE and Gordon Muirhead, GSK 09.00 – 09.15 Opening Comments Alan MacNeice, Chairman ISPE and Gordon Muirhead, GSK 09.15 – 10.30 Regulatory Updates EU Diane Van Riet-Nales (RIVM, Netherlands) Jacques Morénas (AFSSAPS, France) Tor Gråberg (Medical Products Agency, Sweden) Regulatory Issues in Countries not Associated with ICH Dr Lembit Rägo, (World Health Organisation Switzerland) Regulatory Updates USA Dr Moheb Nasr (FDA) Richard Friedman (FDA) Dr Steven Wolfgang (FDA) 10.30 – 11.00 Coffee Break and Exhibition 11.00 – 12.30 Open Q & A with the Regulators 12.30 – 14.00 Lunch and Networking Break |