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.
PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!
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Webinar Training Pass
Recorded on: April 24, 2019
Description: Consultant Nancy Reynolds Howard tackles the nuances and best practices for optimizing reimbursement of clinical trial services. She discusses:
- The relationship between documentation of medical necessity and billing compliance;
- The enhancement of billing compliance using medical necessity language and document consistency reviews;
- The connection between the language used in the informed consent form and billing compliance;
- The nuances of specific codes and modifiers for claims under Medicare’s clinical trial policy and investigational medical device regulations; and
- The importance of complying with Medicare diagnostic and procedural codes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Nancy Reynolds Howard, Consultant, NRH Compliance Partners
Recorded on: April 23, 2019
Description: Former FDA counsel John Fuson explains how to navigate FDA inspections. He discusses:
- Best practices for answering FDA Form 483 observations;
- Strategies for avoiding warning letters and serious enforcement actions;
- Tools for assessing company exposure to regulatory risk; and
- FDA factors that render enforcement or escalation.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John Fuson, Partner, Crowell & Moring, LLP
Recorded on: April 18, 2019
Description:Dan Matlis and Mike Jovanis discuss the application of modern technologies to product lifecycle management. They cover:
- ICH Q12 and its potential benefits;
- How technology can support ICH Q12 and simplify change management; and
- Innovative ways leading pharma companies are addressing PACM.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Daniel R. Matlis, Founder and President, Axendia, and Mike Jovanis, VP-Vault Quality, Veeva Systems
Recorded on: April 4, 2019
Description: Quality systems expert Dan O’Leary explains the hybrid system where you maintain a device certificate under the MDD and a QMS under the MDR. He discusses:
- The dates from the EU-MDR for when the hybrid system can apply;
- The three elements from the MDR Chapter VII – post-market surveillance, market surveillance and vigilance;
- The role of device registration and the required data elements; and
- How to structure the technical documentation for the hybrid system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: April 2, 2019
Description: Compliance experts Cynthia Schnedar and Liz Oestreich offer recommendations on how to build and maintain a culture that values quality and supports data integrity in the manufacturing process. They discuss:
- Best practices in building a culture of quality — including compliance with WHO and FDA data integrity standards;
- The nuances in Commissioner Gottlieb’s statement on achieving drug manufacturing quality; and
- Tips on how to ensure employees are invested in maintaining quality and how to avoid passive non-involvement.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Cynthia Schnedar, Executive Vice President, and Liz Oestreich, Vice President of Regulatory Compliance, Greenleaf Health, Inc.
Recorded on: March 29, 2019
Description: IRB official Kristin J. Craun clarifies key aspects of the revised Common Rule and approaches for educating research teams and ensuring compliance. She discusses:
- How new exempt categories may reduce obligations in human subject protection;
- How new required elements of consent change the standards for informing patients and obtaining consent;
- How the use of continuing review policies apply to minimal risk research and its effect on daily responsibilities in managing clinical trials; and
- How the new Common Rule requirement allows flexibility in some clinical trial areas and the key factors in determining when and how this flexibility can be utilized.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kristin J. Craun, Senior Director, Institutional Review Board, University of Southern California
Note: Due to technical issues, the first 2 minutes of this recording is missing.
Recorded on: March 28, 2019
Description: Cell and gene therapy expert Scott R. Burger discusses the FDA’s requirements for biologics license applications, common mistakes applicants make and how to avoid them. He covers:
- How a cell or gene therapy BLA fits into the framework of the CTD;
- What reviewers in the Office of Tissues and Advanced Therapies expect to see in a BLA; and
- How the earlier stages of development affect the content of the BLA.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Scott R. Burger, Principal, Advanced Cell and Gene Therapy
Recorded on: March 26, 2019
Description: Research integrity expert Donna Kesslier discusses the increased focus on the reliability of research data, honesty in reporting and data reproducibility in an era of heightened competition and pressure. She covers:
- How regulatory authorities are defining research misconduct;
- What are questionable research practices (QRPs), especially in dealing with vulnerable populations; and
- Tips for compliance in conducting proper research in the areas of subject recruitment, consent, recordkeeping and patient outreach and communication.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Donna Kesslier, Research Integrity Officer, Duke University
Recorded on: March 25, 2019
Description: Patient centricity advocates Maggie Buckley, Pamela Bennett and Danya Kaye discuss how to improve clinical trials by involving patients in recruitment efforts, consent agreements, educational materials and engagement. Topics include:
- Things to consider before beginning a patient engagement program;
- Ways to engage directly with patients as advisors; and
- Elements necessary to engage patients and patient advocacy organizations in clinical trial development and treatment.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Maggie Buckley, Volunteer Patient Advocate; Pamela Bennett, Executive Healthcare and Corporate Affairs Consultant; and Danya Kaye, Director of Business Development, R&D and Innovation, Inspire
Recorded on: March 22, 2019
Description: Regulatory expert Lynn Mehler addresses the FDA’s expectations for REMS assessment. She discusses:
- How REMS assessments have changed in the past decade;
- How REMS assessments can lead to additional requirements, separate and apart from modifications to a REMS; and
- How to use REMS assessments to build a case for REMS modification, including elimination of requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Lynn Mehler, Partner, Hogan Lovells
