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!
If you are already a Training Pass member login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video click the "Download Presentation" link.
Select webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.
Already have an account? Login Here.
Webinar Training Pass
Recorded on: March 1, 2018
Description: Clinical trial management experts Richard Young and Ken Getz discuss the impact of real-world evidence on traditional data management systems. They cover:
- Best practices for integrating real-world evidence into the different phases of clinical trials;
- Utilization of real-world evidence to support healthcare coverage decisions;
- How medical product developers are using real-world data to support clinical trial design; and
- Evolving implementation of the 21st Century Cures Act’s provisions regarding use of real-world evidence.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Richard Young, VP, Vault EDC, Veeva Systems, and Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP
Recorded on: Feb. 28, 2018
Description: Biosafety experts Lindsay McNair and Daniel Kavanagh discuss the science of gene therapy and gene editing and the most important ethical challenges inherent in clinical research in rare diseases specific to gene therapy research. Topics include:
- Basic science of gene replacement therapies;
- Examples of therapies in development for rare diseases;
- Specific challenges in the use of gene therapy to treat rare diseases; and
- Ethical issues in research of patients with rare diseases.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Lindsay McNair, Chief Medical Officer, WIRB-Copernicus Group, and Daniel Kavanagh, Senior Director of Biosafety and Gene Therapy, WCG Biosafety
Recorded on: Feb. 22, 2018
Description: Quality systems expert Dan O’Leary explains his supplier metrics system, which includes determining your expectations of the supplier, converting them into measurable characteristics, defining the measurement method, and setting the target. He discusses:
- Requirements from ISO 13485:2016 and additional guidance from the ISO 13485:2016 Handbook;
- Inspection tasks from the FDA’s QSIT;
- Audit tasks from the MDSAP Audit Model;
- Incorporating predictive metrics; and
- Markers of poor performance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: Feb. 22, 2018
Description: Clinical trial specialists Kari Lotsberg and Fabian Sandoval discuss the value of having staff dedicated solely to patient recruitment. They cover:
- The five stages of recruitment;
- Recruitment problems that can stem from lack of time; and
- Benefits of a community recruitment strategy.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kari Lotsberg, Manager of Site Services, ThreeWire and Fabian Sandoval, CEO & Research Director, Emerson Clinical Research Institute
Recorded on: Feb. 21, 2018
Description: Product development specialists Julie Tibbets and Alexander Varond outline strategies for easing the drug approval process. They discuss:
- 21st Century Cures Act implementation update, including FDA guidance development;
- The latest FDA approval pathways — fast track, breakthrough therapy, accelerated approval and priority review; and
- Aligning R&D with regulatory approval pathways.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Julie Tibbets, FDA Partner in the Technology & Life Sciences Group, and Alexander Varond, Senior Associate, Goodwin Procter LLP
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. 15, 2018
Description: European regulatory expert James Pink provides a deep dive into the new EU MDR. He discusses:
- New requirements for documentation confirmation and updating;
- New separate software rules;
- Stricter requirements for implantable devices; and
- Possible sanctions for devicemakers who are not ready to comply with the new rules.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe
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