Pre-conference seminar

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8am	Registration
8.50am	Opening remarks from the Chair Dr. Eleanor S. Segal Dr. Eleanor Segal (“Ellie”) is a family physician and geriatrician who was a clinician/teacher for over 20 years before joining the pharmaceutical industry (Syntex) in 1991. A graduate of the University of Michigan Medical School, she is... more.. › Dr. Eleanor S. Segal, Biopharmaceutical consultant, Consultant
9am	Targeting Receptor or Ligand: Strategic and Safety Considerations Michael Derby DO, PhD Dr. Derby is currently works in LEAD Safety Science with Genentech Research and Early Development, in South San Francisco, California. In this role, his responsibilities focus on ensuring the safety of human subjects in early clinical trials (from... more.. › Michael Derby DO, PhD, Safety Science Leader, LEAD Early Clinical Safety, Global Safety Risk Management, Genentech
9.45am	Non-clinical Safety Evaluation of Biologic Drugs Simon Henderson Simon obtained his PhD from the University of Liverpool and gained 17 years experience in drug development within the contract research industry (Huntingdon Life Sciences). Originally with a background in Drug Metabolism and Pharmacokinetics, Simon... more.. › Simon Henderson, Senior Toxicologist Biologics Safety Assessment, MedImmune
10.30am	Networking and morning refreshments
11am	Safety challenges for antibodies Genevieve Lapeyre Dr Geneviève Lapeyre is a former associate professor anesthesiologist and intensive care specialist from Paris and has more than 20 years experience working in Clinical Development, Medical Affairs and Pharmacovigilance/Risk Management for... more.. › Genevieve Lapeyre, Head of Drug Safety, NoVimmune
11.30am	Case study: Safety challenges for clinical development of biologics
12pm	Lunch
1pm	Safety challenges in clinical development for vaccines
1.30pm	Risk management and active surveillance for vaccines Fernanda Tavares Da Silva Dr Tavares obtained her MD degree and has a specialty in Obstetrics and Gynaecology from the Central University of Venezuela (1992). She has over 19 years of clinical/medical and pharmaceutical experience. Dr. Tavares has held various roles at ... more.. › Fernanda Tavares Da Silva, Therapeutic Area Safety Head, Adjuvants in Vaccines & Immunotherapeutics, GSK Biologics
2pm	Safety challenges for Biosimilars Balwant Heer Qualified & experienced professional with over 20 years of expertise in the effective planning, organisation and conducting Pharmacovigilance, Clinical Research and Medical Affairs activities in compliance with the relevant EU and International... › Balwant Heer, VP, Global Head, Product Safety & Risk Management, QPPV EEA, Mylan
2.30pm	Afternoon refreshments
3pm	Safety surveillance and signal detection for biologics: special challenges and the need of a cross-functional approach Anngret Mallick Anngret Mallick is a physician with 17 years of clinical experience and certifications in inner medicine and nephrology and her last position has head of dialysis before switching to industry in 2008. She is heading the Cardiovascular/hematology... more.. › Anngret Mallick, Group Head TAG Cardiovascular/Hematology, Global Development - Global Pharmacovigilance RM, Bayer Healthcare