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: Feb. 20, 2018
Description: Patient recruitment experts David Borasky and Amanda Plucinak present strategies for expediting study recruitment. They discuss:
- How to develop data to understand why studies are behind schedule and over-budget;
- How to use proven strategies and tactics to improve your patient recruitment numbers;
- How to foster awareness of the importance of implementing appropriate effort into creating a recruitment plan for a study; and
- How to comply with new GDPR requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: David Borasky, Vice President, IRB Compliance, WIRB-Copernicus Group and Amanda Plucinak, Quality Assurance Manager, ThreeWire
Recorded on: Feb. 15, 2018
Description: A panel of clinical research experts discusses the challenges of setting endpoints in studies of rare and orphan diseases in the neurodevelopment space. Topics include:
- Measuring change in core and associated behaviors in autism spectrum disorder;
- Adapting the CGI Scale for developmental disabilities; and
- Applying the old clinical trial model to a new medical research environment.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Brian Rothman, Vice President of Clinical Services, MedAvante-ProPhase; Gahan Pandina, Senior Director and Venture Leader, Janssen Research and Development; Abi Bangerter, Clinical Research Manager, Janssen Research and Development; Michael Aman, Professor Emeritus of Psychology, The Ohio State University; and Mark Opler, Chief Research Officer, MedAvante-ProPhase.
Recorded on: Feb. 14, 2018
Description: Former CDRH Associate Director for Policy Paul Gadiock explains the center’s new total product lifecycle approach that feeds postmarket observations back into premarket data requirements. He discusses:
- The right office to contact after the reorganization;
- The right way to frame your case and make the most persuasive argument;
- Lessons learned from similar reorganizations at CDER and CDRH/OIR; and
- How reorganization may affect CDRH interplay with other FDA bureaus.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Paul Gadiock, Senior Attorney, Arent Fox LLP
Recorded on: Feb. 8, 2018
Description: Regenerative medicine expert Andrew Ittleman explains how the FDA’s regulation of stem cell and HCT/P use is evolving. He discusses:
- How the FDA is interpreting “homologous use,” “minimal manipulation” and “same surgical procedure;”
- Parameters of the FDA’s 36-month enforcement discretion policy;
- The FDA’s new RMAT pathway; and
- Regulation of devices commonly used in regenerative medicine.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Andrew Ittleman, Partner, Fuerst Ittleman David & Joseph PL
Recorded on: Jan. 31, 2018
Description: Quality assurance expert Susan Schniepp explains how to put together a strong internal audit team that can spot issues and deal with them before they become problems. She discusses:
- Better utilizing internal audit observations to drive continual improvement and remediate shortcomings;
- Qualities of effective auditors and team leaders; and
- Good documentation practices — the best prevention against warning letters and other regulatory headaches.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.
Recorded on: Jan. 31, 2018
Description: Combination products expert Angela Pitwood interprets the FDA’s final rule on post-approval safety and reporting for combination products. She discusses:
- Who on the product safety staff should have the responsibility for combination product safety and reporting;
- How to avoid receiving FDA warning letters on combination product reporting and safety; and
- How to implement real-world best practices for safety reporting.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Angela Pitwood, Vice President of Pharmacovigilance, Vigilare
Recorded on: Jan. 30, 2018
Description: Attorney Michael Gaba discusses the FDA’s evolving view of consumer health products under the 21st Century Cures Act. He covers:
- How the Cures Act may set new limits on the FDA’s authority by redefining “medical device” to exclude significant software functions;
- What the agency must do to harmonize its guidance with current law and how this could affect devicemakers’ regulatory decision-making in the interim; and
- The urgent need to re-evaluate existing and planned products that make health and wellness claims.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Michael M. Gaba, Vice Chair, FDA Practice Group, Polsinelli PC
Recorded on: Jan. 26, 2018
Description: Lean Six Sigma expert Miguel Guerrero discusses using lean management principles to improve quality, ensure compliance and boost profit. Topics include:
- Identifying value and mapping the value stream;
- Input Control Templates, a means to reduce or end rework on processes; and
- The “Poke Yoke,” a way of slashing errors in development processes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Miguel Guerrero, Managing Director and Principal, Synergis
Recorded on: Jan. 25, 2018
Description: Clinical trial contracting experts Suzanne Caruso and Brooke Millman discuss negotiating and finalizing site contracts to ensure that you begin your next study holding all the cards: quick startup, decreased costs, no unnecessary terms and conditions that cause hassles and delays. They cover:
- Start-up dates, deadlines, and schedules;
- Necessary and avoidable costs and expenses;
- Air-tight provisions that avoid hassles and complications;
- Enrolling patients to expedite trials and time to market; and
- Payment terms and conditions that meet your budget.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Suzanne Caruso, Vice President , Clinical Solutions, and Brooke Millman, Vice President, Consulting Solutions, WIRB Copernicus Group
Recorded on: Jan. 24, 2018
Description: Attorneys Naomi Halpern and Georgia C. Ravits discuss the intersection of social media and FDA regulation in advertising and promotion. They cover:
- Common social media mistakes that trigger warning letters;
- How to deal with misleading, untruthful and/or biased posts;
- Use of social media for adverse event reporting and product improvement; and
- Likely FDA moves that could affect your use of social media.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Naomi J.L. Halpern, Counsel, and Georgia C. Ravitz, Senior Partner, Arent Fox LLP