Our past webinars are available, free of charge, at the links below.

“Understanding What FDA is Looking for in Postmarket Safety Assessments: Going Beyond AERS” 2-08-2012
“ANDA vs. 505(b)(2)- When and Why?” 12-21-2011
“It’s All in the Details: Tips for Ensuring a Successful NDA Filing” 11-2-2011
“Important Lessons in Developing Biosimilars” 9-28-2011
“Ensuring Successful FDA Meetings” 6-15-2011
“Overcoming Regulatory, Clinical and Quality Challenges in Developing Combination Products” 5-18-2011
“The 505(b)(2) NDA Pathway – An Innovative FDA Strategy that Everyone Should Understand” 4-13-2011
“Drug Safety 2011: What You Need to Know. Bleak House or Great Expectations?” 3-09-2011
“Orphan Drugs–the Challenges & Benefits of Navigating FDA’s Regime Governing Therapies for Rare Diseases”2-23-2011
“Maximizing Audit Efficiencies while Utilizing EDC” 1-19-2011
“FDA Enforcement – The Cop is Back – How Enhanced Enforcement Can Impact You and Your Firm” 12-15-2010
“Taking Full Advantage of the 505(b)(2) NDA Pathway” 11-10-2010
“Increasing GCP Audit Program Efficiency through Outsourcing.” 9-09-2010
Regulatory, Quality & Clinical Due Diligence: The Oft-Overlooked Keys to Successful Transactions. 6-23-2010
Science in the Courtroom. 5-6-2010
Claims-based Marketing and the Importance of Good Science. 4-29-2010
A Look at European Pharmaceutical Regulatory Bodies and Their Interplay with EMEA. 4-14-2010
Recent Sponsor and CRO Warning Letters: What Happened and What We Can Learn 3-10-2010
“Understanding CDRH’s Utilization of New Science in Regulatory Decision-Making.“ 2-24-2010
“Best Practices in Finding and Qualifying Expert Witnesses“ 2-17-2010
“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