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Edwin Rivera-Martinez, Former Chief of the FDA’s International Compliance Branch, Joins PAREXEL Consulting Strategic Compliance Team
Date:11/4/2010

applications (BLAs) and BLA supplement (BLS) applications for therapeutic biological drugs regulated by CDER.

As the Agency’s leading drug expert on the International Conference on Harmonization (ICH) Q7 Expert Working Group, Mr. Rivera-Martinez played a key role in the development and implementation of the ICH guidance entitled “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.”  For the last two and a half years, he also served as the Agency’s technical drug CGMP expert on the ICH Q11 Expert Working Group tasked with developing an internationally harmonized guidance for the development and manufacture of drug substances.

From 1990 to 2002, Mr. Rivera-Martinez served as Compliance Officer in DMPQ.  Prior to transferring to CDER, he worked for 13 years as an Investigator in the FDA’s San Juan, Puerto Rico District office, where he specialized in the inspection, auditing, and investigation of complex, state-of-the-art active pharmaceutical ingredient and drug production facilities.  From 1988 to 1990, while in San Juan, he participated in a joint Pan American Health Organization (PAHO)/FDA cooperative program. As a Regional Consultant in PAHO’s Essential Drugs Program, he coordinated and presented six drug quality assurance and CGMP training courses in Latin America that resulted in the training of over 400 drug regulatory authority and industry personnel.

“The appointment of Mr. Rivera-Martinez to PAREXEL’s team of strategic compliance and regulatory experts reinforces our commitment to helping clients proactively manage the risk of potential safety issues, as well as product delays and failures on a global scale,” said David L. Chesney, Vice President and Practice Lead, Strategic Compliance Services, PAREXEL Consulting.  “Extremely well-versed in regulations, CGMP compliance and enforcement, as well as ICH guidance, he brings a level of t
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