FDAAA 2007 * ICMJE guidances * Maine Law * PhRMA and IFPMA guidances * Impending EudraCT uncloaking * CTRI * ChiCTR * WHO ICTRP

 

Wherever you look there is evidence of a growing storm of activity around clinical trial registration and results disclosure (CTRR). This mandatory registration for most protocols and full disclosure of trial result summaries within a year of primary (outcome) completion date has significant implications for publication planning professionals.

 

This webseminar examines current state of CTRR from its epicenter to its ever-expanding margins. It then walks delegates through the implications for publication professionals and suggests practical strategies to help insure that your primary journal publication is timed as close as possible to your result disclosure.

 

Key Learning Points:

Who should purchase:

 

You will benefit from purchasing this event if you are a Manager, Director or a Supervisor at a pharmaceutical, biotech or medical device organization with responsibilities or involvement in the following areas or departments:

Medical/Clinical Publication

Medical Communication

Scientific Communication

Medical Writer

Medical Information

Medical Affairs

Clinical Affairs

Clinical Operations

Clinical Data Management

 

About our Presenters:

Barbara Godlew is the President and Principal Analyst of The FAIRE Company, which serves to provide pharmaceutical/biotechnology/medical device companies with senior-level experience consulting, quality assurance, and operation management services related to clinical trial disclosure requirements. Barbara also has been a registered nurse since 1981.

As a result of her involvement with the Drug Information Association's Clinical Trial Registry and Results Database Working Group, Barbara was elected chairperson of this group in 2009. Based partially on her efforts, the working group has conducted three annual 2-day workshops on clinical trial disclosures and has built a close working relationship with the National Institutes of Health's ClinicalTrials.gov staff.

Barbara assists clients in developing internal strategies to comply with the Food and Drug Administration Amendments Act (Title VIII), Maine law on clinical trial disclosure, and the European Medicines Agency regulations on clinical trial disclosure. Barbara has been active in clinical trial disclosure initiatives since 2004, when her first venture required her to develop policies and operations strategies as the Clinical Trial Disclosure Operations Lead for Novartis Pharmaceuticals Corporation.

 

Tim Bacon is a founding supporter and inaugural President of the International Society for Medical Publication Professionals (ISMPP, www.ismpp.org) and led the development of the ISMPP certification initiative. He is also Executive Vice President of Sylogent (www.sylogent.com), a leading provider of technology-driven solutions that support both publication planning and clinical trial registration and results disclosure (CTRR) activities.

Mr. Bacon worked for more than 14 years in the pharmaceutical industry with responsibilties for both local UK and global strategy. Subsequently he worked for more than 11 years in the medical communications industry where he worked with Adis (now Wolters Kluwer) and Thomson Scientific (now Thomson Reuters). During this time Mr. Bacon led a variety of publication planning and medical communications teams.

 

In 1999, Mr. Bacon founded PeerView, a company that developed the industry-leading conference and journal profiling databases and also developed innovative publication planning and investigator-initiated trial approval solutions. PeerView was acquired by Sylogent in 2009, at which time Mr. Bacon assumed his current position.