Dr. Bernstein will work with the Budapest Working Group to update International Conference on Harmonisation guidelines for developing clinical study protocols and reports
PRINCETON, NJ – Mar. 19, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that Aaron Bernstein, Ph.D., director of global submissions for Synchrogenix, its regulatory and medical writing consultancy, has been appointed to the European Medical Writers Association’s Budapest Working Group (BWG) to help update the International Conference on Harmonisation (ICH) E3 and ICH E6 guidelines. Introduced 20 years ago, these are the current regulatory guidelines for developing clinical study protocols and clinical study reports. Dr. Bernstein will represent the American Medical Writers Association on the BWG.
“Global pharmaceutical R&D has changed dramatically in the 20 years since ICH E3 and ICH E6 were issued,” said Synchrogenix CEO Kelley Kendle. “New transparency regulations, such as European Medicines Agency Policy 70 which was enacted earlier this year, are creating a growing need to disclose clinical trial information publicly. The ICH guidelines need to be updated to reflect current clinical practices. Dr. Aaron Bernstein has the requisite regulatory expertise and will prove to be a terrific asset to the BWG.”
BWG is a collaboration between professional associations, regulatory agencies, and key industry participants in the drug development space. By involving key stakeholders, such as the U.S. Food and Drug Administration, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, Health Canada, the Drug Information Association, and the Clinical Data Interchange Standards Consortium early in the process, the European Medical Writers Association hopes to ensure that the proposed recommendations will address the needs of the broadest possible community.
Dr. Bernstein has more than 20 years’ experience as a regulatory writing and business analyst. He has been instrumental in creating and leading writing teams that develop clinical and regulatory documents for submission to health authorities worldwide. His therapeutic areas of expertise include metabolic diseases, HIV/AIDS, and cardiology.
An overview of the BWG ICH 3 project is available at http://www.maneyonline.com/doi/full/10.1179/2047480614Z.000000000254.
About the International Conference on Harmonisation (ICH)
Launched in 1990, ICH brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United States. ICH’s mission is to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines. For more information, please visit http://www.ich.org/home.html.
About Synchrogenix, Powered by ClinGenuity, a Certara™ Company
Synchrogenix, Powered by ClinGenuity, a Certara company, encompasses a group of separate entities operating together to provide regulatory and medical writing services to the pharmaceutical, biotech, and medical device industry worldwide. Synchrogenix Information Strategies Inc.; Synchrogenix Europe, Ltd.; and Synchrogenix Philippines, Inc. (SPI) are all wholly owned subsidiaries with an overall governance structure that creates and enforces a global standard of service, technology, and quality.
Certara（サターラ）について
Certara is the global biosimulation technology-enabled drug development and drug safety consulting company. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit www.certara.com.
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