Strategies for Rare Disease Studies and Orphan Drug Development in Europe

Clinical Trials, Drug Discovery and Development, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • May 14, 2013 | 10am BST (UK) / 11am CEST (EU-Central) / 5am EDT (NA)
  • 0 min

Recording not available for this webinar

Tap into the knowledge of two seasoned drug developers from Premier Research for a webinar packed with practical, experience-based guidance. Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical and regulatory challenges on the path to successful orphan drug development.

Speakers

Susan Tansey, MD, Medical Director, Paediatrics, Premier Research

Dr. Susan P. Tansey, specialty areas include vaccines, cardiovascular, and oncology, although her initial training was in neonatology and pediatric medicine. She has considerable experience in pediatric clinical research and trial design. Dr. Tansey’s expertise in developing detailed clinical development strategies in the pediatric therapeutic field will further strengthen a Premier Research team that brings to the table a wealth of experience in rare disease and pediatric research. Dr. Tansey has considerable international experience in the Pharmaceutical industry, having joined Premier Research from TMC Pharma Services Limited, where she was director of medical services. She previously had held research positions at Pfizer, Wyeth Research, and Servier R&D.

Susan Bhatti, PhD, Executive Director European Regulatory Affairs and Medical Writing, Premier Research

Dr. Susan Bhatti has spent over 15 years working in Regulatory Affairs in both the Pharmaceutical industry and for contract research organisations. Currently she is Executive Director European Regulatory Affairs and Medical Writing at Premier Research and is responsible for managing all the European regulatory activities of the company. She has been directly involved in assisting Pharmaceutical companies with Orphan Drug applications and is aware of the need to ensure that the Orphan Drug strategy and accompanying clinical studies reflect the long term strategic development plans for a product. As she is also closely involved in feasibility requests, study proposals and clinical trial submissions, Dr Bhatti is very familiar with the practical challenges associated with conducting clinical trials in orphan indications.

Who Should Attend?

VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

  • Clinical Affairs
  • Clinical R&D
  • Clinical Research
  • Clinical Pharmacology
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Affairs

for pharmaceutical, biotechnology and medical device companies

Xtalks Partners

Premier Research

At Premier Research we focus on doing what we do best, and on putting all the pieces together to take our customers from proof of concept to regulatory approval. To do that, we have developed a surprising concentration of experience for a mid-sized CRO:
Over 600 trials for virtually every major class of analgesic, including every NSAID pain medication on the market today.
Three times as many medical device studies as the world’s largest CRO.
Pediatric experience with both familiar and extremely rare childhood illnesses, including work at PICUs, NICUs, clinics, and ERs – and a hard-to-match track record of successful neonatal studies.
For the future, we plan on continuing to focus on serving the needs of the small, highly innovative Pharmaceutical and biotechnology companies whose developments are changing medical history, especially in the areas of pediatric medicine and rare diseases. We will offer them everything they need to transform brave new ideas into life-saving therapies.

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