November 15, 2011

Webinars to review regulatory requirements and strategies for professionals at all levels involved in drug development; kick-off Dec. 7 webinar will review regulatory needs at start-up companies.

Future webinars will present expert guidance on meeting with the FDA, developing orphan drugs, and use of foreign data in US regulatory submissions.

CAMBRIDGE, MASS  (November 15, 2011) -- PROMETRIKA, LLC, a contract clinical research organization serving the biopharmaceutical industry, announced the launch of a series of free webinars on U.S. regulatory affairs topics.  The 90-minute webinars will offer expert guidance on regulatory issues for industry, academic and government professionals at all levels who are involved in drug and biological clinical research and new product development and commercialization.

The first webinar, entitled “Regulatory Affairs for Start-Up/Virtual Drug Development Companies,” will be held from 12 noon – 1:30 PM on Wednesday, December 7, 2011.  Presenters include Roberta Tucker, RPH and Elizabeth Fenna (Partners, RegRx Consulting LLC – PROMETRIKA’s regulatory affairs consultants), who will review the regulatory affairs issues and requirements that face smaller companies involved in executing clinical research programs and developing healthcare products in the U.S.  They will highlight the range of professional services and expertise required to execute drug development programs in compliance within mandated guidelines and prevailing regulatory standards.

“As a clinical research organization, PROMETRIKA has developed special expertise and contacts in all areas of planning and execution for clinical trials.  In our new webinar series, leading experts will review the requirements that companies conducting clinical research find especially challenging.  They will also identify effective solutions to help research professionals address these challenges successfully.  This training can help to improve interactions with the FDA, reduce costs and maximize the chances of success in clinical stage research,” said Miganush Stepanians, Ph.D., president and CEO at PROMETRIKA.

Webinars will also review the regulatory requirements and options to help company managers plan for the full range of regulatory expertise and support they need to execute a clinical trial in the United States.  Topics to be covered in future webinars include:

  • a review of best practice strategies for FDA meetings;
  • special considerations in developing orphan drugs; and,
  • opportunities to use foreign data in US regulatory submissions.

The schedule for future webinars will be posted on the PROMETRIKA web site ( in the coming weeks. 

“We plan to schedule webinars about 4-5 weeks apart to make this a convenient series for many industry professionals to plan to join.  This training will provide important new insights on regulatory affairs for CEOs and senior managers, entrepreneurs, regulatory affairs teams, clinical researchers, and medical professionals,”  Dr. Stepanians said.

Advance registration is required for each of the webinars in the series.  To register, visit



Founded in 2003 in Cambridge, Mass., PROMETRIKA, LLC, is a contract research organization that offers a full range of integrated clinical research services to its pharmaceutical and biotechnology clients, including clinical trial management, clinical monitoring, data management, biostatistics, medical writing and regulatory submissions. PROMETRIKA's team has extensive expertise and experience in managing clinical trials, analyzing and interpreting medical data, and preparing new drug applications for US and European regulatory agencies in a broad range of therapeutic areas, including cardiovascular disease, dermatology, gastrointestinal disease, inflammatory and metabolic disorders, oncology and respiratory disease. Collectively, the PROMETRIKA team has managed more than 200 clinical trials, ranging from Phase 1 pharmacokinetic crossover trials to Phase 4 long-term multi-center studies.


Additional information about PROMETRIKA products and services is available at or by contacting Chris Gallant at (617) 868-2020 x223.


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