Upcoming Webinars



“Recent Sponsor and CRO Warning Letters: What Happened and What We Can Learn.“

A Webinar Presented by The Weinberg Group

Wednesday, March 10, 2010

12 p.m. (ET) | 11 a.m. (CT) | 10 a.m. (MT) | 9 a.m. (PT)

Join Carol Bognar, Senior Director, as she discusses what can be learned from the recent warning letters regarding clinical practices that have invalidated major trials over the last year. Carol is an experienced regulatory professional with a broad range of Quality Assurance experience, including over 15 years in Clinical Auditing. Join her as she answers the following questions:
  • Why did one of the largest pharmaceutical companies receive a scathing Warning Letter from the FDA?
  • Was there fraud and/or misconduct activity detected by the FDA at one of the clinical sites?
  • What should you be doing now to safeguard the integrity of your clinical trials and data?
  • What lessons can be learned from recent FDA actions?
This complimentary, one-hour, invitation-only webinar is designed for clinical, quality and regulatory professionals to help them understand what actions they should be taking to protect the investments they are making in their clinical trials.

To learn more, please contact Tim Mullane.





Past Webinars

“Understanding CDRH’s Utilization of New Science in Regulatory Decision-Making.“  02-24-2010

“Best Practices in Finding and Qualifying Expert Witnesses“  02-17-2010

“Understanding What FDA is Looking for in Post Market Safety Assessments: Going Beyond AERS.“  12-16-2009

“A Stricter FDA: How Will it Impact the 510(k) Process?“  12-02-2009

"European Regulation on Advanced Therapies"  10-21-2009

“ANDA vs. 505(b)(2) - When and Why”  9-30-2009

“The Politics of Science - What Corporations Can Learn from NGOs”  9-16-2009

“FDA’s New Strategy on Enforcement – the Growing Perils of Inadequate Compliance"  9-9-2009

“Evaluating Product Risk in a Rapidly Changing Environment”  6-3-2009

“Global Lessons in Developing Biosimilars”  5-27-2009

“FDA Call for Data on non-PMA Class III Devices - Key Points To Consider”  4-20-2009

“Pharmaceutical Development in Europe – Key Points to Consider"  4-15-2009

“The Top Ten Ways to Ensure Successful FDA Meetings"  3-2-2009

“Medical Monitoring: Igniting Future Litigation and Strategies for Defense”  2-19-2009

“The Ten Most Common Obstacles to Meeting Your Development Milestones”  1-29-2009



 
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