The IFPMA reception on the occasion of the 68th World Health Assembly

Mr. Hiiti Baran Sillo

Director General Tanzania Food and Drugs Authority (TFDA) Ministry of Health and Social Welfare of Tanzania

Mr. Hiiti Sillo is the Director General of the Tanzania Food and Drugs Authority (TFDA) from June 2011 after acting in the same capacity since May 2010. Prior to his current position, he served the TFDA on several technical and managerial positions including being the Director of Medicines and Cosmetics between 2008 and 2011.
Mr. Sillo is one of the pioneers of the African Medicines Regulatory Harmonization (AMRH) Initiative. He is a member of the East African Community (EAC) Medicines Regulatory Harmonization (MRH) Project Steering Committee since its launch in March 2012 and the current chair of EAC MRH Progamme.
Mr. Sillo is a career Medicines Regulator and a registered Pharmacist with vast regional and international experience in medicines regulation and quality assurance of pharmaceuticals. He served WHO Prequalification of Medicines Programme as a Quality Assessor from 2003 to 2010 that included working as a Technical Officer at WHO HQ in Geneva on a rotational position in 2007. He serves in various technical and advisory Boards and Committees at national, regional and international level. Some of these include Regional Working Group on SSFFC Medical Products in the WHO African Region, WHO Working Group on Access to Assured-Quality Essential Medicines for Neglected Tropical Diseases (WGA) and WHO Strategic and Technical Advisory Group (STAG) on Antimicrobial Resistance.

Dr. Lembit Rägo

Head, Regulation of Medicines and other Health Technologies Essential Medicines and Health Products World Health Organization (WHO)

Dr Lembit Rägo, PhD, was a Professor of Clinical Pharmacology (Tartu University) and founder and first Director General of the Estonian Drug Regulatory Authority, State Agency of Medicines. In December 1999, he joined World Health Organization (WHO) Headquarters, Geneva, as Coordinator of Quality Assurance and Safety: Medicines (QSM) team which included activities related to International Nonproprietary Names (INNs), Quality Assurance, Pharmacovigilance, Regulatory Support, Fighting Falsified Medicines, Prequalification of Medicines and Quality of Blood Products and Related Biologicals. During 2000/2001 Dr Rägo laid the foundations for the WHO Prequalification of Medicines Programme and has continued to contribute to its development ever since. Since 2002 he has been the main organizer of WHO biennial International Conference of Drug Regulatory Authorities (ICDRA) bringing together regulators from around 100 countries all over the World. From September 2013, Dr Rägo is serving as the Head of WHO’s newly formed unit, Regulation of Medicines and Other Health Technologies, which covers norms and standards, safety, prequalification and regulatory strengthening for medicines, vaccines and diagnostics. Since 2000 he has also been a WHO observer to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Steering Committee, ICH Regulators Forum and ICH Global Cooperation Group (GCG) and also serves as a member of the Uppsala Monitoring Centre Board which hosts the WHO Global Database of Individual Case Safety Reports (ICSRs or Adverse Drug Reaction reports). He is frequent speaker in different international fora and has numerous publications on regulatory affairs, medicines quality and safety issues.

Dr. Nathalie Strub-Wourgaft

Medical Director Drugs for Neglected Diseases initiative (DNDi)

Dr. Nathalie Strub Wourgaft joined DNDi as Clinical Development Director in February 2009. Dr. Strub, who most recently served as Director, Clinical Development at Trophos, has over 15 years of clinical development experience, including with Pfizer from 2000 to 2003, and Lundbeck from 1995 to 1999. She also served as Medical Director for a CRO from 2004 to 2005 as well as for the French office of Aspreva from 2005 to 2008. Dr. Strub graduated as Medical Doctor from Necker Hospital, Université René Descartes in Paris in 1983.

Mr. Stefano Malvolti

Director, Vaccine Implementation Gavi, the Vaccine Alliance

Stefano Malvolti is currently Director Vaccine Implementation at the GAVI Alliance Secretariat in Geneva. Stefano is responsible for the coordination of the 11 Alliance’s global immunization programs across the 73 countries eligible for GAVI support. The work leverages on the strong partnership with UNICEF, WHO, the Bill & Melinda Gates Foundation as well as other public partners. As part of this role, Stefano leads the work of definition of the Alliance new Coverage and Equity strategy and represents GAVI in the Immunization Management Group of the Global Polio Eradication Initiative and in the WHO’s Ebola Vaccine Deployment Steering Committee. Stefano has 15 years of experience in both public and private health (PATH, Novartis, Baxter amongst others) in a variety of functions including program management, strategy supply chain, and policy. Stefano gained an MSc in Business Economics from University ‘Luigi Bocconi’ (Milan, Italy) and further executive education from IMD (Lausanne, Switzerland) and is completing his Master in Public Health at Johns Hopkins Bloomberg School of Public Health (Baltimore, USA).

Ms. Sharon Olmstead

Chair, Regulatory Policy and Technical Standards Committee International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. In this position, she manages teams based in Europe, North America, and Asia-Pacific responsible for global development policy and regulatory intelligence activities within Drug Regulatory Affairs.

Prior to rejoining Novartis, Sharon was named Head of U.S. Regulatory Policy at Merck after the acquisition of Schering-Plough. She joined Schering in November 2003 as vice president of regulatory policy and intelligence following similar regulatory positions at Pharmacia and Novartis.

Sharon worked at the Food and Drug Administration (FDA) for six years prior to working in the pharmaceutical industry. She held several positions of increasing responsibility including Consumer Safety Officer in the Division of Metabolic and Endocrine Drug Products, Consumer Affairs Specialist in the Office of the Commissioner and Science Policy Analyst in the Office of the Center Director, Center for Drug Evaluation and Research.

Sharon began her career as a Biological Research Technician at the Uniformed Services University of the Health Sciences, participating in preclinical research in the areas of spinal cord injury and behavioral pharmacology. She received a bachelor’s of science in biology from Old Dominion University in the US.