Simplifying Global Compliance
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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: 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. 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
Recorded on: Oct. 18, 2018
Description: Metrics experts Linda Sullivan and Keith Dorricott discuss approaches trial sponsors are taking to comply with ICH E6(R2). They cover:
- New risk-based quality management requirements described in ICH E6(R2) section 5.0;
- The importance of critical thinking in risk assessment and risk control;
- The meaning of high and low detectability and the relevance to risk prioritization; and
- Leading practices to improve risk assessment and quality oversight.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Linda Sullivan, Executive Director, Metrics Champion Consortium, and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.
Recorded on: Oct. 18, 2018
Description: FDA compliance expert Ricki Chase digs into the details of the CDER revamp and explains how it could affect drugmakers. She discusses:
- How the Office of New Drugs is organized now and how it will change;
- What the FDA says is the goal of restructuring, and opportunities and challenges that could result;
- The specific impact on new drug application reviews; and
- How the restructuring may affect critical CDER and FDA functions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ricki A. Chase, Director, Compliance Practice, Lachman Consultant Services Inc.
Recorded on: Oct. 17, 2018
Description: Quality metrics experts Steven Mendivil and Denyse Baker explain the latest developments in the FDA’s quality metrics plans. They discuss:
- How the agency’s site visit pilot program is progressing and what the FDA has learned so far;
- How to take advantage of opportunities to provide input to the FDA before it drafts regulations to implement the program, including contact with appropriate agency personnel;
- The FDA’s latest draft guidance on quality metrics; and
- Major industry concerns, such as metrics selection and definitions, and how the agency is addressing them.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Steven Mendivil, Senior Advisor for Quality/External Affairs, Amgen, and Denyse Baker, Senior Policy Director-U.S. Regulatory Affairs, AstraZeneca
Recorded on: Oct. 16, 2018
Description: Regulatory expert Karla Palmer explains the FDA’s 2018 Compounding Priorities Plan. She discusses:
- How sections Secs. 503A and 503B of the 2013 Drug Quality and Security Act (the “Compounding Quality Act”) affect compounding pharmacies and outsourcing facilities;
- Changes brought about in FDA draft and final guidances;
- What enforcement actions FDA has taken against compounders to date and what could lie down the road; and
- The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Karla Palmer, Director, Hyman Phelps & McNamara P.C.
