Life Science Compliance Update

March 19, 2018

FDA announces Public Meeting on Evaluating Inclusion and Exclusion Criteria in Clinical Trials on April 16


On April 16 from 8:30am to 5pm, the FDA will be holding a public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The event is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.


The public meeting will be held at the National Press Club, 529 14th St. NW, Washington, DC 20045. For additional travel and hotel information, please refer to the following website. There will also be a live webcast for those unable to attend the meeting in person. For further information, contact Dianne Paraoan at the FDA’s Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796-2500,

Topics for discussion during this meeting include:

  • The risks and benefits of participation in clinical trials as well as potential regulatory, geographical, and socioeconomic barriers to participation.
  • The rationale for eligibility criteria in clinical trials, as well as the impact of exclusion criteria on the enrollment of populations, such as infants, children, pregnant and lactating women, elderly, individuals with advanced disease, and individuals with co-morbid conditions.
  • Alternative clinical trial designs that may increase enrollment of more diverse patient populations, while facilitating the collection of data to establish safety and effectiveness.
  • How appropriate patient populations can benefit from the results of trials that employ alternative designs.
  • How changes to eligibility criteria may impact the complexity and length of clinical trials, as well as the strength of data necessary to demonstrate safety and effectiveness.
  • Opportunities for using data from expanded access trials.



February 20, 2018

12th International Pharmaceutical and Medical Device Compliance Congress


This May, the 12th International Pharmaceutical and Medical Device Compliance Congress will take place in Vienna, Austria, at the Hotel Savoyen, from the 14th through the 16th.

Keynote speakers for this conference include: Nicola Bedlington, Secretary General, European Patients Forum (EPF), Former Director, European Disability Forum, Brussels, Belgium; Jan Oliver Huber, General Secretary, Association of the Austrian Pharmaceutical Industry (PHARMIG), Vienna, Austria; Camilla de Silva, Joint Head of Bribery and Corruption, Serious Fraud Office, London, UK; and George “Ren” McEachern, CFE, CAMS, Managing Director, Exiger, Former Supervisory Special Agent, International Corruption Squad, US Federal Bureau of Investigation, Washington, D.C.

Co-Chairs of the event include: Dante Beccaria (Sanofi, Paris, France); Stephen Nguyn Duc (Rungis, France); Suzanne Durdevic, LLM (Boston Scientific International, Paris, France); Dominique Laymand, Esq. (Ipsen, Paris, France); and Roeland Van Aelst (Johnson & Johnson, Brussels, Belgium).

The event was just announced on February 8, 2018, and a call for proposals has been sent out. If you are interested in submitting a proposal, you may do so here.

To register for this conference, click here, or call (800) 503-8171. Standard conference registration is €1,795 (est. $2,198.05) through March 16, 2018; €1,995 (est. $2,442.96) through Friday, April 13, 2018; and €2,195 (est. $2,687.87) after Friday, April 13, 2018.

February 06, 2018

Tomorrow: CMS To Host Open Payments Webinar/Q&A


Tomorrow, February 7, 2018, the Centers for Medicare and Medicaid Services (CMS) will be hosting a Webinar and Question and Answer session with CMS Open Payments program experts from 2:00 pm to 3:00 pm EST. CMS has been hosting these every few months for stakeholders to get some of their important questions answered.

During this webinar/Q&A session, the Open Payments team will present an overview of system enhancements and data submission activities and will then be able to respond to your questions about the 2017 Open Payments program year.

If you have a question, you must go online and register at least fifteen minutes prior to the webinar here. Once you are registered, you will receive an email with instructions on how to join the call and ask a question.

If you do not have a question, but want to listen to the call to gain insightful information, you can dial in to (844) 396-8222 and enter meeting number 900 984 780 when prompted.


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