The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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Webinar Training Pass
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
Recorded on: Feb. 20, 2019
Description: Regulatory expert Mary Vater shares best practices for preparing and submitting 510(k) applications as FDA policies evolve. She discusses:
- What specific changes the FDA has made to the 510(k) process;
- How to identify a suitable and favorable predicate device;
- How the FDA is addressing the changing biocompatibility requirements; and
- The best time to file your pre-submission.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mary Vater, Medical Device Consultant, Medical Device Academy, Inc.
Recorded on: Feb. 19, 2019
Description: Attorney and pharmacist Lee Rosebush addresses newly proposed standards for outsourcing. He discusses:
- Implementing best practices to protect against contamination;
- Ensuring that a compounder conducts sterility assurance activities for sterile products and microbiological quality activities for non-sterile products; and
- Conducting annual quality standard evaluations of drug products.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Lee H. Rosebush, Partner, Baker Hostetler