Stay current on the ever-changing biotechnology regulatory environment with 10 audio recordings of industry experts offering insight on federal guidance, challenges, and best practices for biotechnology companies.
Ovid and FX Conferences offer thousands of professional development hours for your teams, conveniently packaged and delivered as a collection of audio recordings to save you time and money.
Topics in this collection have a global appeal and are relevant for multiple departments within your organization—R & D, Market Research, Compliance, and more. Each of the 10 recordings consists of a 45-minute, telephone-based presentation delivered by expert international speakers, followed by a 15-minute question-and-answer session (collection available with and without transcripts).
1. Centralized vs Onsite Monitoring – Applying FDA's Risk-based Approach
Speaker: Sandra Maddock, President & CEO, IMARC Research, Inc.
2. Implementing the FDA Guidance on Investigator Responsibility
Speaker: Lorry Witte, RN, BA, CCRC, CCRA, Clinical Research Consultant
3. FDA Update – Responding to Unsolicited Requests for Off-Label Information
Speakers: Marian J. Lee & Beverly H. Lorell, MD - King & Spalding LLP
4. Off-label Promotion – What FDA Looks For & What You Need to Know
Speaker: Alan Minsk, Partner, Arnall Golden Gregory LLP
5. Writing Clinical Data Queries – Best Practices and Pitfalls
Speaker: Rick Brogden, Clinical Data Analyst, INC Research
6. Site Visit Follow-up – Letters, Notes to File and CAPA Plans
Speaker: Amy Adams, Clincial Project Manager, SAIC-Frederick, Inc.
7. Optimizing the Bioprocessing of Future Research Samples: Focusing on Integrity, Quality and Control (webinar)
Speakers: Dr. Andrew Brooks, COO, RUCDR Infinite Biologics and R. Aleks Davis, Associate Director of Comprehensive Solutions and Scientific Advisor with BioStorage Technologies, Inc.
8. Biomedical Applications and Considerations for Hydrogels
Speaker: Stephen Spiegelberg, President, Cambridge Polymer Group, Inc
9. Who Owns What? Patent Ownership Issues with the Exchange of Biotechnology
Speaker: Kattina V. Barsik, Intellectual Property and Registered Patent Attorney
10. Industry Update – European Human Tissues Regulation
Speaker: Richard van der Linden, Senior Consultant Signifix