Making expedited regulatory pathways work for global drug development programs

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/pathways

Event Overview:

Expedited programs can potentially cut years from the average overall time to market. But they are most useful for companies that have defined a target product profile (TPP) and identified the right mechanism or a combination of mechanisms. With many differing expedited regulatory mechanisms available across the globe, how can you select the right pathway and make it work simultaneously in different regions? This panel discussion will include a lively conversation with Parexel regulatory experts from USA, Europe, and China, who will draw upon their experience as former regulators and share their first-hand experience of regulator expectations. The discussion will address:

Key Learning Objectives:

• Selecting the right expedited regulatory pathway for a global program
• Overcoming challenges of expedited mechanisms in different regions
• Top tips for working with regulators
• Identifying the right evidence for marketing approval

Who Should Attend:

• Small to mid-sized biotech and pharma
• Regulatory and clinical functions
• Manager and above

Speakers

Lucas Kempf
Vice President, Regulatory Consulting
Parexel, United States

Lucas has over 15 years of industry experience. He was the former Director of Rare Disease program Office of New drugs and former team lead for Psychiatric Products for the CDER FDA. He co-authored inter-center and intra-center draft and final Guidances to Industry on drug development for common issues for rare diseases drug development, natural history studies, pre-IND meetings, rare pediatric priority review voucher programs, and eligibility criteria, among other specific rare disease guidances.

Yajie Li
Vice President, Regulatory Consulting
Parexel, China

Yajie leads China regulatory strategy consultation, responsible for providing strategic technical guidance on various clinical and regulatory aspects of drug development. Yajie has over 20 years of clinical and drug development experience. She has held several senior positions at Merck (China), Innovent (Suzhou), Johnson & Johnson (China), and Xuanzhu Pharm and also worked as a senior clinical reviewer in the Center for Drug Evaluation (CDE) at the China NMPA.

Bridget Heelan
Vice President, Regulatory Consulting
Parexel, UK/EMEA

Bridget advises clients on their clinical development plans, performs gap analyses, and supports with the writing and reviewing of MAAs, NDAs, scientific advice briefing documents, ODD applications, and responses to clinical questions from regulatory authorities. Prior to joining Parexel, Bridget was a senior clinical assessor in the biological unit at the MHRA, chaired the Rheumatology Immunology Working Party at the EMA and the UK delegate for the Committee for Advanced Therapies. She was also a consultant clinical immunologist in the NHS.

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/pathways