Mailing List Sign-Up
Attendee Comments:
"Content was excellent. Size was very conducive to discussions and exchange of information."
"Great Conference, promoted good exchange of information - all of the speakers were very knowledgeable."
"First practical approach I've seen for these topics."
"A lot of interesting and good points to consider and keep in mind during protocol writing"
"Very Informative"
"Good Content and Information that was new to me!"
"In late phase clinical research we must represent ourselves as an ambassador of [our client], representing the pharmaceutical company with enthusiasm and pride. We strive to become an extension of the company as opposed to a contractor working in isolation."
Risk Management in Drug Safety Conference
May 22-23, 2006
Marriott Downtown
Philadelphia, PA
Overall Conference Feedback:
The recent Risk Management in Adverse Events & Drug Safety conference took place this May 22-23 in Philadelphia and was of tremendous value to the industry executives that attended the program. Feedback was centered around relevant presentations from industry leaders, audience interactions that enabled attendees to directly question and challenge not only speakers but other attendees as well as practical approaches to challenges that drug safety executives face today. As one attendee noted:
"This conference was very valuable - the presentations were excellent, the size of the group was great and the Q1 staff did a good job of organizing and assisting attendees. I will recommend Q1 to the rest of my company!"
Sessions Addressed Included:
Benefit-Risk in the Management of Drug Safety
Mohan Bala, PhD
Director, Outcomes Research
Centocor, Inc.
*Feedback from this session noted that this was a very practical approach to be taken within drug safety divisions; Dr. Bala provided excellent materials and raised questions that would continue to be discussed throughout the two days of the conference program.
Adverse Event Reporting: Past, Present & Future Directions
Lisa J. Zimmerman
VP Quality Assurance
POZEN
*Ms. Zimmerman's session provided a critical evaluation of adverse event reporting, which gave attendees an excellent overview of the challenges and tasks ahead, with take-home approaches to be included in protocol writing for the future.
Pre-Approval Clinical Drug Safety
Steven Lin, MD
Director, Pharmacovigilance
Millennium Pharmaceuticals, Inc.
*Dr. Lin's session also received excellent feedback, highlighting the pragmatic and relevant material that was outlined during his presentation. The session also provided an excellent vision of future direction in drug safety during pre-approval scenarios.
Building a Risk Management and Pharmacovigilance Plan with a Global Reach
Serge Novikov, MD, PhD
Director, Drug Safety & Pharmacovigilance
Barrier Therapeutics
*The presentation led by Dr. Novikov was extremely relevant, especially to individuals from organizations dealing with various cultures - leading back to the importance of creating a company-wide objective centered around drug safety.
Public and Patient Usage and Expectations for Clinical Trial Registries
Roni Thaler
President
Center for Information & Study on Clinical Research Participation (CISCRP)
Partnering with IRBs to Enhance Compliant SAE Reporting
Jeffery Trunzo
VP, Business Development
Chesapeake Research Review
Spontaneous Reporting of Adverse Events
Wenjun Jiang, MD, MPH
Pharmacoepidemiology Fellow
Benefit & Risk Management Division
Johnson & Johnson
If you attended this conference program but were unable to update your materials, we'd be happy to provide you with the updated slides - just email us at: Info@Q1Productions.com
