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: 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- FDA draft guidance on OTC innovation;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
Recorded on: Feb. 14, 2019
Description: Regulatory experts Nicholas Mitrokostas and Daniel Orr discuss recent developments in regulation of biosimilars. They cover:
- Modernizing policies governing the development of biosimilars to make it more efficient;
- Educating clinicians, payers and patients about biosimilar products and the rigorous evaluation they must go through; and
- Modernizing regulatory policies to accommodate new scientific tools that better enable comparison between biosimilars and reference products that may reduce the need for clinical studies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Nicholas Mitrokostas, Partner, Goodwin Procter LLP, and Daniel Orr, Partner, Womble Bond Dickinson LLP
Recorded on: Feb. 13, 2019
Description: Supply chain consultant Evren Ozkaya explains how to prepare for upcoming serialization and track-and-trace requirements. He discusses:
- Lessons learned from the first five years of implementation of the Drug Supply Chain Security Act;
- How to setup the right foundation for digital supply chain management; and
- New technologies (e.g., Blockchain, Internet of Things) that will define supply chain capabilities.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Evren Ozkaya, Founder & CEO, Supply Chain Wizard, LLC
Recorded on: Jan. 30, 2019
Description: Regulatory expert James Rogers explores the nature and regulation of software as a medical device (SaMD). He discusses:
- The process for classifying an SaMD based on U.S. and international guidance;
- How a company’s use of a software product impacts the classification of SaMD;
- When a purchased software product becomes an SaMD; and
- Remediation approaches to resolve SaMD compliance issues.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Rogers, Founder, Compass Life Science Solutions
Recorded on: Jan. 29, 2019
Description: Regulatory expert Tiffany Guckin explains the nature and content of investigator’s brochures (IB) and IND annual reports. She discusses:
- The importance of annual reports to the FDA and sponsors;
- Structure and content of an IB per ICH E6 (R2);
- How to ensure you are accurately representing your investigation to potential subjects; and
- Best practices that can be included in SOPs or other regulatory processes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tiffany Guckin, Associate Director of Regulatory Affairs, Invicro
