RAPS 2012 Session Schedule

Anderson has covered many aspects of drug development during over 30 years in the pharmaceutical and biotechnology industry. She has held several positions which have included regulatory affairs, drug development, and due diligence for licensing. She has arranged and been involved in meetings with many world agencies including the FDA, and the EMA, including a successful CHMP arbitration. Anderson has assisted with the Drug Development Plans at various stages of development for biologics and pharmaceuticals and successfully brought them to market globally. She has experience in various therapeutic areas including CNS, Oncology, Hematology, Dermatology and Rheumatology. She has achieved orphan designations for 6 pharmaceutical products (EU and US). She has held senior positions with Professional Associations and has presented in International forums. Patricia leads a talented team of regulatory professionals that produce client specific regulatory and development strategies and solutions for global and local market needs. Anderson’s team have provided successful drug and device solutions for 100’s of clients over the last 10 years.

Michor is founder and CEO of Michor Consulting e.U, serving such clients as Johnson & Johnson , Novartis, Valeant Pharma and Colgate Palmolive. Previously, Michor worked in regulatory and quality assurance with Chiesi-Torrex and Wyeth Whitehall export, and as director of supporting operations at Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. Michor served on the RAPS Board of Editors, 2005–10, and is a member of the RAPS European Advisory Committee. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the EU RAC.

Since qualifying in 1983 Humphreys has worked in the area of development pharmaceutics for a national branded generics manufacturer and an international research and development company. In 1991 he joined the International Regulatory Affairs Division of Glaxo Group Research Limited where he was responsible for the development and submission of a series of international registration applications in a number of therapeutic areas. He joined the EMA in May 1996 and is currently the head of sector for regulatory, Procedural and Committee Support. Within this capacity he is responsible for provision of secretariat support to the CHMP, CMDh, CAT, HMPC, provision of regulatory advice and guidance concerning human medicinal products within EMA and to applicants/marketing authorisation holders and co-ordination of Community Referral procedures.

After completing his PhD. in Pune, India, Shailesh joined Intercell in 2001 as a Staff scientist working in the Antigen identificatin program aimed at finding and characterizing potential vaccine candidates against bacterial diseases. He later started his career in Regulatory group in 2005. As a core project team member of the Japanese encephalitis vaccine project, he was involved in the strategy, planning of the Phase 3 trials of JE vaccine which was critical for IPO of Intercell. He headed the expanding Regulatory group from 2007 till July 2010. During his tenure, Intercell compiled, filed and received approvals for their first vaccine in US, EU, Australia, Canada and Switzerland sometimes simultaneously. During his leadership, the group also sucessfully implemented eDMS, eCTD tools for submissions to various regulatory agencies. During his regulatory career he not only provided strategic regulatory input to the Intercell projects but also participated in numerous interactions/negotiations with the regulatory agencies like FDA, EMA, PEI, MHRA, Health Canada, AGES regarding diverse development aspects of Interell's vaccine. Currently he is VP, Toxicology at Intercell looking also at developmental aspects of upcomming products at Intercell.

Merete Schmiegelow, M.Sc. (Pharm.), B. Medicines, B. Business, M. Communication, Director of Regulatory Policies and Intelligence, Novo Nordisk A/S Merete Schmiegelow has worked in several pharmaceutical industries for more than 30 years of which the last 27 years have been at Novo Nordisk A/S. She has a very broad experience in all drug development disciplines as well as project management for various therapeutic development projects. Within Regulatory she has more than 17 years experience covering all regulatory disciplines in the life cycle of development projects and of products. She has driven an EU affiliates management group as well as ensured a company smooth regulatory entrance of the 12 latest EU member states. Today she is Director of Regulatory Policies and Intelligence and very active within several EU Trade Associations (EuropaBio, EFPIA and EBE). She is spokesperson for an EU Variation topic group within EuropaBio.

Simanko has more than 12 years of experience in global regulatory affairs and drug development. Main areas are in the field of RA for biologics, both on development products, including clinical trials in EU, US and internationally, as well as life cycle management of vaccine products. Walter's experience also encompasses RA activities involved in contract manufacturing and development with partner companies and governments (e.g. US government contracts under the Influenza program), RA operations activities and electronic submissions (eCTD, SPL). Prior to Intercell, Simanko was Senior Manager Global RA at Baxter. He is a guest lecturer for Drug RA at the FH Krems (University of Applied Sciences in Austria)

Dr. Veronika Jekerle studied pharmacy in Marburg, Germany and at the Université de Paris 11, Paris, France and graduated with a Pharmacy graduate degree from the Phillips University, Marburg in 2001. She proceeded to postgraduate studies at the University of Bonn, Germany and the University of Toronto, Canada. Her research focused on transporter-mediated multidrug resistance in cancer therapy. She has several publications in Peer review journals and her research was funded by the Deutsche Forschungs Gemeinschaft (DFG) and the Government of Canada Award. Dr. Jekerle joined the European Medicines Agency in London, UK in early 2006. Veronika started work in the Pharmacovigilance sector and Regulatory Affairs Sector, and subsequently joined the Quality of Medicines Sector in 2007. She is currently working in the Biologics Section, where she manages marketing authorisation applications, classification procedures and scientific advice procedures for vaccines, recombinant proteins and cell and tissue engineered products. Dr. Jekerle was deeply involved in the implementation of the new regulation on Advanced Therapy products at EMA and works closely with the Committee of Advanced Therapies (CAT). She currently holds the position as scientific secretary to the Cell Products Working Party (CPWP) where she coordinates the drafting of several scientific EMA guidelines including the Guideline on the risk-based approach for ATMPs. Dr. Jekerle has represented the EMA on topics related to EU regulatory affairs at the University of Toronto Graduate Pharmacy Program training course, National Competent Authorities, European Patent Office and several international symposia (e.g. DIA, ISSCR). She is author of publications in the area of Advanced Therapies Regulation in Europe and has completed a fellowship at the Office of Cellular, Tissue and Gene Therapies (OCTGT-CBER) at FDA.