Simplifying Global Compliance
The Webinar Training Pass
Now get all the training you need – all in one place, and all for one low price!
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: 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
Recorded on: March 21, 2019
Description: Attorney Jessica Ringel discusses how the FDA will prioritize its regulatory efforts in 2019, including:
- Recent revisions to the medical device guidance and activities required by the FDA Reauthorization Act (FDARA);
- Nuances pertaining to quality and regulatory professionals included in CDRH’s FY 2019 guidance agenda; and
- Status of the ever-evolving voluntary FDA pilot programs.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jessica Ringel, Counsel, King & Spalding
Recorded on: March 20, 2019
Description: : Pediatric trial experts Lisa Benson and Janelle Allen discuss how to deal with the differences and challenges faced while conducting pediatric clinical trials. Topics include:
- How to develop study budgets specific to pediatric clinical trials, including recruitment and administrative costs;
- Approaches to recruitment in pediatric research, including the pros and cons of using different forms of standard and social media;
- How to identify the challenges faced when conducting pediatric clinical trials; and
- Strategies for successful retention of children in clinical trials.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Lisa Benson, Senior Vice President of Research, Education and Quality, and Janelle Allen, Director of Research, Education and Quality for the Institute of Advanced Clinical Trials for Children
Recorded on: March 19, 2019
Description: Medical device expert J. Lawrence Stevens discusses trends in the FDA’s regulation of integrated devices. He covers:
- FDA premarket and postmarket requirements for medical imaging devices;
- How to interpret and comply with the FDA’s imaging guidance; and
- The agency’s plans for future medical imaging regulation.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: J. Lawrence Stevens, Principal Consultant, One Way Consultants, LLC
Recorded on: March 18, 2019
Description: Regulatory expert Christine Kirk provides an update on recent developments in OTC regulation. She covers:
- Significant OTC monograph reform legislation currently pending in Congress (H.R. 269);
- FDA draft guidance on OTC innovation;
- Recent OTC-related enforcement actions; and
- Common areas of confusion and key compliance issues.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Christine Kirk, Food and Drug Group associate, Arnall Golden Gregory healthcare practice
Recorded on: Feb. 27, 2019
Description: Regulatory experts Bethany Hills and Aaron Josephson outline the FDA’s evolving compliance policies for devicemakers. They discuss:
- What areas the FDA targeted in inspections in 2018 and has focused on for enforcement in 2019;
- The nuances in compliance areas that create risk and should be closely monitored in your quality system; and
- Enforcement tools the FDA will be using in 2019 to ensure compliance.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Bethany J. Hills, Chair, FDA Practice, Mintz Levin, and Aaron Josephson, Senior Director, Mintz Levin
