Webinars


Taking Advantage of the Orphan Drug Act – Webinar

In this webinar, Marla Scarola, M.S., Senior Consultant, The Weinberg Group, helps senior life science executives understand how to best take advantage of the significant opportunities provided by the Orphan Drug Act.
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Single and Shared REMS Systems: The Past, Present and Future Webinar

In this webinar, Emily Krulewitz, Research Associate, The Weinberg Group, helps senior life science executives understand the complex elements of REMS and prepare for the creation and implementation of a single or shared system REMS.
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Advisory Committees – It All Comes Down to This – Webinar

In this webinar, Matthew Weinberg, CEO, The Weinberg Group Inc., discusses various stratagems that can be utilized, and pitfalls that can be avoided, in order to achieve optimal results at the advisory committee level.
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Clinical Data Management and the Cult of Quality – Webinar

In this webinar, Nick Cohen, M.S., Manager, GCP Services, The Weinberg Group, discusses the elements of data quality and how to approach it before, during, and after the conclusion of a clinical research effort.
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Orange Book as a Strategic Resource – Webinar

In this webinar, Dr. Nick Fleischer, R.Ph., Ph.D., Vice President, The Weinberg Group, discusses the questions answered by FDA’s Orange Book.
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All in the Details – Tips for Ensuring a Successful NDA Filing – Webinar

In this webinar, Dr. Bob Roth, M.D., Ph.D. Vice President & Worldwide Medical Director, The Weinberg Group, discusses the elements beyond the nonclinical, clinical and CMC content that are vital for NDA filing and review.
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Ensuring Successful FDA Meetings – Webinar

In this webinar, Dr. Nita Patel, Ph.D. Vice President, The Weinberg Group, discusses how to maximize success when meeting with FDA regulators.
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Understanding What FDA is Looking for in Postmarket Safety Assessments – Going Beyond AERS – Webinar

In this webinar, Dr. Bob Roth, Ph.D., M.D. Vice President & Worldwide Medical Director, The Weinberg Group, helps decision makers and regulatory affairs professionals understand what FDA is looking for in postmarket safety assessments.
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Maximizing Audit Efficiencies while Utilizing EDC – Webinar

In this webinar, Amy Hansen, former Manager, GCP Services, The Weinberg Group, helps viewers discover how to maximize compliance by building efficiencies when utilizing Electronic Data Capture (EDC).
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New Biosimiliars Guidance – Has Anything Changed? – Webinar

In this webinar, Bob Roth, M.D., Ph.D., Vice President & Worldwide Medical Director, The Weinberg Group, and Nick Fleischer, R.Ph., Ph.D., Vice President, Clinical Pharmacology & Biopharmaceutics, The Weinberg Group, help life science executives understand the market opportunity in pursuing biosimilars.
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