5 June 2012 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast tomorrow, 6 June, at 12:00 pm EDT, addressing the regulatory challenges of today’s rapidly developing personalized medicine technologies.
Regulatory bodies are beginning to develop guidance and communications for personalized medicine, but companion diagnostic regulatory submissions are advancing more quickly. As a result, challenges exist in anticipating regulatory requirements for the approval of drugs with companion diagnostics. This RAPS webcast, Conquering Today’s Regulatory Challenges to Realize Personalized Medicine, will examine current challenges and evolving regulatory trends. Christine Gathers, senior director, Eli Lilly and Company, will take a critical look at case studies, available tools and strategic considerations along the co-development pathway to enable efficient development, risk mitigation and generation of supportive evidence to meet regulatory body requirements.
• Christine Gathers, senior director, Eli Lilly and Company
90-minute webcast entitled Conquering Today’s Regulatory Challenges to Realize Personalized Medicine
6 June, 12:00–1:30 pm EDT
How to Access:
Members of the working media may request access to this live RAPS webcast or to the recording by contacting Zachary Brousseau, senior manager, communications, RAPS, at firstname.lastname@example.org or +1 301 770 2920, ext. 245.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org