Regulatory Affairs Professionals Society Webcast to Explore Regulatory Issues in Developing Genetic Diagnostic Kits

21 June 2011 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast Wednesday, 22 June, that will explore the regulatory, clinical, strategic and legal issues involved in developing genetic diagnostic kits for the US market. The current regulatory requirements and processes for placing a genetic test on the US market are not clear. The US Food and Drug Administration (FDA) has recently taken action against manufacturers of some genetic kits, prompting even more uncertainty in the field. This webcast will examine the current status of US regulatory processes, development strategies, marketing scenarios and statistical strategies for developing genetic diagnostic kits.

Who:

- Mukesh Kumar, PhD, RAC, senior director, regulatory affairs and quality assurance, Amarex Clinical Research

- Kazem Kazempour, PhD, chief, statistical team, CEO and president, Amarex Clinical Research

What:

90-minute webcast entitled Developing Genetic Diagnostic Kits for the US Market: Trends and Regulatory Insight

When:

22 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 zbrousseau@raps.org or +1 301 770 2920, ext. 245.

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org