Press Releases
Aaron Bernstein Appointed to International Group Updating ICH Guidelines on 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 Associations 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. ICHs 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.
About Certara
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. Certaras 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.
