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: Oct. 24, 2017
Description: Organizer and chair of the 2017 Expanded Access Drug Summit Jess Rabourn explains the new proposed best practices for integrating cohort Expanded Access into the drug development process. He discusses:
- Preapproval access requirements, including key provisions on cost recovery;
- Prevailing business practices for sponsoring Expanded Access programs; and
- Capturing real-world evidence and the differentiating factors of treatment response.
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Transcript: Download the transcript
Speaker: Jess Rabourn, Founder, WideTrial
Recorded on: Oct. 19, 2017
Description: Regulatory expert Dan O’Leary untangles the web of regulations for IVDs. He discusses:
- Technical and practical definitions of various types of IVDs;
- The distinction between “finished devices,” “investigational products,” and “research products;”
- Premarket submission paths; and
- Labeling requirements.
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Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: Oct. 12, 2017
Description: A panel of experts discusses the outlook for devicemakers under FDA Commissioner Scott Gottlieb. They cover:
- New guidance documents aimed at medical devicemakers;
- Gottlieb’s big-picture approach to device regulation;
- What role patients will play in device development and approval; and
- How the FDA will sort out knotty issues surrounding combination products.
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Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Marc Scheineson, Partner, Alston & Bird LLP; Mahnu Davar, Partner, Arnold & Porter/Kaye Scholer
Recorded on: Oct. 5, 2017
Description: Quality systems experts Tom Middleton and Mike Edwards discuss quality management factors that lead to success. They cover:
- Why the life sciences industry must emphasize quality over mere compliance;
- Current and emerging guidelines and regulations aimed at improving medical device and pharmaceutical product quality; and
- The challenges posed to mid-sized and emerging life sciences manufacturers.
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Speakers: Tom Middleton, Solutions Architect, and Mike Edwards, Senior Product Manager, Sparta Systems
Recorded on: Sept. 28, 2017
Description: A panel of industry experts discuss the FDA’s view of 3D printing of medical devices. They cover:
- Training surgeons to use 3D-printed models;
- Applications of 3D printing across the product lifecycle;
- Hurdles companies have faced in implementing 3D printing operations; and
- Bio-printing models of human cells and organs for use in clinical trials.
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Speakers: Thomas Marchand, CEO, BIOMODEX; Jenny Chen, CEO, 3DHEALS; Stavros Stefanis, Leader, Deloitte's Product Development Practice; Jennifer Petrosky, Director of Life Sciences Industry Marketing, Dassault Systèmes; and Daniel Matlis, President, Axendia
Recorded on: Sept. 26, 2017
Description: Quality systems specialist Dan O’Leary explains statistical techniques mandated under the FDA’s Quality System Regulation (§820.250). He discusses:
- The difference between variables data and attributes data;
- The concept of process variability and its common metrics;
- Valid statistical techniques in the context of FDA’s QSR; and
- How to apply this information to your manufacturing processes.
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Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: Sept. 19, 2017
Description: Antitrust law expert August Horvath presents real-life scenarios that illustrate what you can and cannot say in advertising. He discusses:
- How misleading impressions occur, including why viewers misinterpret efficacy claims;
- How to list side effects to avoid misinterpretation;
- How to head off FDA or FTC actions against alleged unsubstantiated medical and comparison claims; and
- Proven techniques for substantiating claims.
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Speaker: August T. Horvath, Antitrust Partner, Kelley Drye
Recorded on: Sept. 14, 2017
Description: FDA experts Wayne Pines, Jill Hartzler Warner and Dan Kracov discuss FDA Commissioner Scott Gottlieb’s first months in office, including:
- What the Gottlieb FDA is likely to continue and what will likely change;
- What unannounced priorities the commissioner may advocate in the future; and
- Gottlieb’s record and regulatory inclinations as well as unfolding events.
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Speakers: Wayne Pines, President, Health Care APCO Worldwide; Jill Hartzler Warner, VP of Regulatory Policy, Catalyst Healthcare Consulting; and Dan Kracov, Partner, Arnold & Porter Kaye Scholer LLP
Recorded on: Sept. 13, 2017
Description: John Balzano, an expert on China’s medical device regulations, explains the current environment for devicemakers doing business in China, including:
- General reforms of China’s administrative system;
- Influence of reforms in other spaces; and
- Reform of the Chinese healthcare system.
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Speaker: John Balzano, Special Counsel, Covington and Burling, LLP
Recorded on: Sept. 12, 2017
Description: Supplier accreditation experts Connie Conboy, Paul Hugo and Scott Goolsbey outline the benefits of using the MedAccred program to audit and certify suppliers. They cover:
- Meeting FDA requirements for purchasing controls;
- Verifying suppliers’ critical process capabilities;
- Evaluating suppliers’ equipment, personnel and controls; and
- How MedAccred audits differ from quality system audits.
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Speakers: Connie Conboy, Director, Strategy & Business Development, Performance Review Institute; Paul Hugo, Director, Corporate Quality, Global Technologies; and Scott Goolsbey, Supplier Controls Manager, Stryker