Recorded on: Jan. 15, 2019

Description: Cybersecurity expert Norma Krayem discusses the rapidly changing global IT security regulatory landscape. She covers:

• Cybersecurity-triggered changes in the interpretation of HIPAA and enforcement by the HHS Office of Civil Rights;
• Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms;
• FDA’s evolving focus on cybersecurity and how it impacts the risk, responsibilities and regulation of companies; and
• The Cybersecurity Information Sharing Act (CISA) and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors.”

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Norma Krayem, Senior Policy Advisor and Co-Chair, Cybersecurity and Privacy Team, Holland & Knight

Recorded on: Jan. 10, 2019

Description: GMP expert Dan O’Leary explains how to collect samples of records for an audit. He discusses:

• Concepts of sampling applied to quality audits;
• The difference between a nonconformance and nonconformities;
• The use of (non-statistical) convenience samples; and
• The role of the binomial distribution in audit sampling.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: Dec. 18, 2018

Description: Attorneys Stephanie Resnik and Christopher Hanson outline the FDA’s new medical device voluntary malfunction disclosure program. They discuss:

• How the program differs from individual malfunction reporting;
• How the program will help increase devicemakers’ efficiency; and
• Conditions under which the program is not available to manufacturers.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Stephanie Resnik and Christopher Hanson, Associates, Covington & Burling LLP, Washington, DC

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