Pharmacovigilance: Partnering for Patient Safety
20 November 2012
10.30 to 12.00
Restaurant Vieux-Bois (Salon Dunant)
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On 20 November 2012, the IFPMA hosted a Geneva Pharma Forum titled “Pharmacovigilance: Partnering for Patient Safety.” With a special focus on biotherapeutic medicines, the event highlighted the role that pharmacovigilance systems play in assessing the safety profile of a medicine throughout its lifecycle and in protecting patients.
Moderated by Dr. Otmar Kloiber, Secretary General of the World Medical Association, the event featured presentations from Dr. Shanthi Pal (WHO Program Manager for Pharmacovigilance), Dr. Fermin Ruiz de Erenchun (Roche; Chair of IFPMA Biotherapeutics Group) and Mr. Jeremiah Mwangi (Director of External Relations for the International Association of Patient Organizations).
The speakers discussed the work carried out by their respective organizations to highlight the importance of developing and implementing pharmacovigilance standards and of raising public awareness. They also discussed the recent European Union pharmacovigilance legislative developments. Because biotherapeutic medicines are more complex products with distinct product characteristics compared to most chemically-synthesized small molecule medicines, the identification and traceability of individual biotherapeutic medicines are essential, and all stakeholders have a role in ensuring robust pharmacovigilance for biotherapeutic medicines.
Introduction & Welcome- IFPMA
Dr. Shanthi Pal
Programme Manager for Pharmacovigilance
Quality Assurance and Safety of Medicines,
World Health Organization
Dr. Fermin Ruiz de Erenchun
IFPMA Biotherapeutics Group Chair
(F. Hoffmann-La Roche)
Dr. Jeremiah Mwangi
Policy and External Affairs Director
International Alliance of Patients’ Organizations
Moderated panel discussion and Q&A
Fermin Ruiz de Erenchun studied Medicine in the University of Navarra (Pamplona, Spain). He holds a degree in dermatology, and a doctorate from the University Clinic of Navarra. In 1993, he joined Hoffmann La Roche’s Spanish office, then in 1999 moved to Roche’s corporate headquarter in Basel (Switzerland). Between 2008 and 2010, he was General Management of Roche Peru in Lima. During the last 3 years, he has been engaged in meeting with National Regulatory Agencies in Europe and around the world to discuss and contribute to the implementation of biosimilar pathways. Since 2011, he chairs the biotherapeutic group at the International Federation of Pharmaceutical Manufactures & Associations (IFPMA) in Geneva, Switzerland.
Dr Otmar Kloiber was appointed as Secretary General of the World Medical Association in February 2005. Before joining the WMA, Dr Kloiber served as Deputy Secretary General of the German Medical Association. As WMA Secretary General, he is the head of its Secretariat and is responsible for managing and directing the WMA staff and the activities of the WMA. He provides overall leadership and strategic direction to the organisation and represents the WMA to the Association’s members, the medical profession, the international community, representatives of government, the business community, and the public.