Tim Felgate, Owner of reg-info.com, UK
Tim studied physiology at St Andrews University and University College London. He is the founder of the informative website www.reg-info.com and has over 20 years international experience. Projects include regulatory advice and support from the early stages of the drug development process through to marketed products, as well as for numerous therapeutic areas. Recently Tim has joined the Weinberg Group as Vice President

Mayte Fresneda, Associate Director at Cellerix, Spain
Mayte has a degree in Pharmacy, and two Masters, one in Pharmaceutical and Parapharmaceutical Industry, and the other in Regulatory Affairs. During the last 11 years she has worked for several international companies (pharma and CROs). She has regulatory experience with a wide range of pharmaceutical products and indications, as well as other related fields such as cosmetics, pharmacovigilance, and clinical research.

Alex Kanarek, Principal of AK Consulting, Canada
Alex has more than 30 years of experience in the biopharmaceutical industry He established his consulting practice in 1993, specializing in regulatory compliance in biopharmaceutical development laboratories and manufacturing plants. Dr. Kanarek is the author of Guides to Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice, Good Validation Practice and Good Facility Design. He is on the editorial advisory board of the BioProcess International journal.

Shylendra Kumar, President / CEO at Datafarm, USA
Shylendra has global responsibility for Datafarm's strategic direction, future development and innovations pipe-line. Prior to starting Datafarm, Shylendra was a Research Data Analyst at Boston University and Consultant in Clinical Data Analysis and Electronic Submissions to AstraZeneca and Genzyme. With a B.Sc and M.A. from Bangalore University, India, and an MPH from Boston University, USA, he has assisted sponsors with thousands of electronic submissions since 1997.

Cristina Meran, Independent Consultant, Italy
Cristina graduated in Pharmacy and is currently a regulatory consultant based in Milan, Italy. She has over 30 years experience in the pharmaceutical field covering research & development, regulatory, and licensing responsibilities. For the last 10 years she has been working as an independent consultant focusing on dossiers' registration and maintenance in Italy on behalf and in cooperation with European and overseas companies.

Paul Crick, Head of CMC Regulatory Affairs at Laboratorios Almirall
Paul graduated in chemistry and did research in medicinal and photochemistry and worked in scientific writing and translation. For the last ten years he has specialized in Chemistry, Manufacturing and Controls Regulatory Affairs, working with a wide range of indications and dosage forms for both approved and investigational products. Latterly he is working with respiratory indications and inhaled and combination products.

Mwate Mulenga, Animal Biotechnologist, Government of Canada
Mwate studied at Cairo, then in the US at the University of Queensland and Humber College and holds a BVSc, MVSt,and Hon.CerRAP. She has 24 years experience in veterinary medicine, microbiology and regulatory affairs, and has worked for the Zambian, Australian and now the Canadian government. Currently she is reviewing industry submissions for product licensing and is developing animal biotechnology policy.

Tamas Paál, President of the Hungarian Institute of Pharmacy.
Tamás graduated in pharmacy. He became President of the National Institute of Pharmacy, the Hungarian medicines regulatory agency, this year, after twenty-five years as Director-General. He accepted his first professorship in 1984 & currently lectures at the Institute of Drug Regulatory Affairs in Szeged, Hungary. He holds awards from RAPS, DIA and TOPRA and has published more than 170 papers on medicine evaluation, analysis and good practice.

Paul Wiener, CEO at GxP Associates, USA.
Paul Wiener is a compliance consultant working out of his home office in Kendall Park, New Jersey, USA After retiring from FDA as a field manager with 37 years experience, he worked for 4 years as a compliance director for two global pharma mfrs, and for the past 4 years has worked as an independent consultant performing audits, testifying as an expert witness and helping firms overcome compliance issues with the FDA.