Simplifying Global Compliance
The Webinar Training Pass
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The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
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Webinar Training Pass
Recorded on: Dec. 12, 2018
Description: Quality systems experts Mike Jovanis and J.P. Zonnenberg explain how modern solutions can lead to more informed quality decisions and faster innovation. They discuss how technology can:
- Support the shift from compliance to product and patient focus;
- Enable greater insight and better decisionmaking;
- Seamlessly engage stakeholders across the development lifecycle; and
- Transform business process for real-time responsiveness.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mike Jovanis, VP, Vault Quality, Veeva Systems; J.P. Zonnenberg, Partner, Co-Lead, Quality Management Systems Practice, PwC
Recorded on: Dec. 6, 2018
Description: Attorneys Chad Landmon and Suchira Ghosh discuss the FDA’s efforts to expedite generic drug approval. Topics include:
- The new pathways to expedited approval of generic drug applications, including 180-day exclusivity;
- Recent FDA policy statements and guidance on generic drugs and their impact on regulatory and quality professionals; and
- Substantive changes to REMS standards that impact ANDAs.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Chad Landmon, Partner, and Suchira Ghosh, Counsel, Axinn, Veltrop and Harkrider
Recorded on: Dec. 5, 2018
Description: Attorneys Mike Druckman and Blake Wilson discuss the potential impact on laboratory-developed tests, in vitro diagnostics and targeted therapies of the Diagnostic Accuracy Innovation Act (DAIA) if it is passed in the next session of Congress. Topics include:
- How the legislation would change the FDA’s oversight of in vitro diagnostic products and affect pre- and postmarket requirements;
- How the DAIA defines low-risk and high-risk test;
- Circumstances under which an existing product will need to seek marketing approval from the FDA; and
- What enforcement powers the FDA may be granted.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mike Druckman, Partner, FDA pharmaceutical group, Hogan Lovells; Blake Wilson, Senior Associate, FDA medical device group, Hogan Lovells
Recorded on: Nov. 29, 2018
Description: Hastings Center’s Rosemary Gibson discusses Chinese manufacturers’ impact on the global supply chain. She covers:
- Three lessons from the valsartan case;
- The rationale for proposed tariffs on Chinese medical products;
- Details of the industry response to tariffs on Chinese-made APIs and chemical intermediates; and
- The importance of China’s goal to become the world’s pharmacy and the impact on the global supply chain and regulatory oversight.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Rosemary Gibson, Senior Advisor, Hastings Center
Recorded on: Nov. 28, 2018
Description: Attorney Anne Walsh discusses the evolution of REMS requirements and recent lawsuits resulting from noncompliance. She covers:
- The recently changed requirements evolving REMS from a safety initiative to a powerful enforcement tool;
- The most successful strategies to defend against a False Claims Act case based on compliance with safety requirements; and
- Recent settlements and what they mean.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Anne K. Walsh, Director, Hyman, Phelps & McNamara, P.C., Washington, DC
Recorded on: Nov. 27, 2018
Description: Patient communication and compliance experts Jill McNair, David Forster and Behtash Bahador discuss best practices in presenting research results to study participants. Topics include:
- Working with IRBs that oversee the clinical trials for which patient summaries are provided;
- Case study of one sponsor’s collaboration with IRBs during the plain-language summary creation and delivery process; and
- Upcoming regulations that may affect how you provide trial results to participants.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jill McNair, Senior Director-Patient Engagement, The Center for Information and Study on Clinical Research Participation (CISCRP); Behtash Bahador, Senior Manager for the Communicating Trial Results Program, CISCRP; David Forster, Chief Compliance Officer, WIRB-Copernicus Group
Recorded on: Nov. 14, 2018
Description: Regulatory specialists Jennifer Nowak and Sara Klock provide insight into what the FDA will regulate as medical device technology and what may cause the technology to require premarket review. They discuss:
- The agency’s groundbreaking pilot program that determines whether the clearance process can and should be updated;
- How the FDA’s recent final guidance affects regulatory specialists; and
- How the FDA is addressing potential vulnerabilities, such as cybersecurity risks.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jennifer Nowak and Sara Klock, Associates, Holland & Knight, Public Policy & Regulation Group
Recorded on: Nov. 7, 2018
Description: Biotech consultant Nitisha Pyndiah explains how the FDA is modernizing its biosimilars policies. She discusses:
- Interchangeability vs. biosimilarity — understanding the differences under the BPCI Act;
- The development and implementation of new FDA review tools;
- Enhancements to the Purple Book, including more information about approved biological products; and
- The significance of the BsUFA II fees.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Nitisha Pyndiah, Consultant, HartmannWillner
Recorded on: Nov. 1, 2018
Description: Pharmaceutical and medical device attorney Michael Burke discusses the implications of the EMA’s upcoming move out of the UK and how resulting staffing and logistical problems may disrupt the regulator’s operations. He covers:
- Legal uncertainty regarding contracts involving both the UK and other EU member states;
- How staffing and logistical problems resulting from the agency’s move to Amsterdam may disrupt its operations; and
- The impact of the separation on international harmonization efforts.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Michael Burke, Partner, Corporate Practice, Arnall Golden Gregory
Recorded on: Oct. 30, 2018
Description: Quality management expert Dan O’Leary explains the risk-based approach to auditing featured in the latest edition of ISO 19011. He discusses:
- The seven principles of auditing;
- Differences between the 2018 and 2011 versions of 19011;
- Types of audit sampling and when to use them; and
- Evaluating auditor competence.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
