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: July 18, 2018
Description: Electronic submissions expert Antoinette Azevedo explains the technical and organization challenges of complying with the FDA’s eCTD specifications:
- How to avoid a refuse-to-receive when submitting your eCTD;
- Strategies for developing a roadmap for implementing the technical and organization components for eCTD success;
- Real world impact of eCTD format on your CMO and CRO partners; and
- The impact of eCTD on submissions to the rest of the world health authorities.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Antoinette Azevedo, President & CEO, e-SubmissionsSolutions.com
Recorded on: July 17, 2018
Description: FDA official Owen Faris provides a view into FDA’s thinking and activities related to the use of real-world evidence (RWE) and the National Evaluation System for Health Technology (NEST). He discusses:
- Why the FDA is promoting the use of RWE to evaluate medical devices;
- Proof of concept as it applies to using RWE for device evaluation; and
- How RWE and NEST can specifically apply to medical device development.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Owen Faris, Director of the Clinical Trials Program, CDRH
Recorded on: July 11, 2018
Description: Regulatory compliance expert Connie Hoy explains the Medical Device Single Audit Process. She discusses:
- Using the companion document as a preparation guide;
- Ensuring your quality system covers specific country requirements;
- Questions auditors are likely to ask; and
- How the process differs from FDA inspections and ISO audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Connie Hoy, President, Hoy & Associates Regulatory Consulting
Recorded on: June 21, 2018
Description: Clinical research compliance experts Jennifer Mallory and Carrie Hanger provide an overview of changes in the Common Rule set to take effect in January 2019. They discuss:
- Broad consent for secondary research;
- Limited and continuing IRB review;
- Exemptions;
- Federalwide assurances; and
- Cooperative research.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jennifer Mallory and Carrie Hanger, partners, Nelson Mullins Riley & Scarborough
Recorded on: June 20, 2018
Description: Pharmaceutical serialization expert Bill Fletcher discusses emerging trends in serializing drug products, track and trace systems and FDA and global regulation. He covers:
- Child-to-parent aggregation;
- Complexities of the Drug Supply Chain Security Act;
- Traceability based on third-party logistics; and
- Implementing Electronic Product Code Information Services.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Bill Fletcher, Managing Partner, Pharma Logic Solutions LLC
Recorded on: June 14, 2018
Description: Quality systems expert Dan O’Leary explains the process of setting and measuring quality objectives to meet regulatory requirements. He discusses:
- Methods an FDA Investigator uses to verify compliance;
- Additional requirements from ISO 13485:2016;
- A description of the three types of metrics; and
- How to use Excel to develop a graphical approach to the metrics.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: June 13, 2018
Description: Acting Associate Director for Regulatory Affairs Tamy Kim explains the Oncology Center of Excellence mission to expedite the development of oncology and hematology medical products and support an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer. She discusses:
- The center’s structure, including where it sits within the agency and how it interacts with other centers;
- Nuances of the regulatory role, such as the formation of clinical review teams for oncology products;
- Elements of OCE research; and
- Examples of OCE outreach, including interactions with professional societies and patient or advocacy groups.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tamy Kim, Acting Associate Director for Regulatory Affairs in the Oncology Center of Excellence
Recorded on: June 7, 2018
Description: Attorneys Gilliam Russell and Heather Banuelos discuss FDA and FTC trends in regulating advertising and promotion of medical products. They cover:
- Key focus areas and emerging trends;
- Risk disclosure;
- How such elements as music selection, pacing and distracting visuals can result in an enforcement letter; and
- FTC’s increasing focus on transparency as it bears on novel promotional strategies.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Gillian M. Russell, Counsel, and Heather Banuelos, Counsel, King & Spalding
Recorded on: June 5, 2018
Description: Clinical research expert Daniel Kavanagh discusses registration and reporting requirements for gene therapy research under the recently revised NIH guidelines. He covers:
- NIH reporting compliance;
- The Office of Science Policy registration process; and
- Progress and safety reporting requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Daniel Kavanagh, Senior Director of Biosafety and Gene Therapy, WCG Biosafety
Recorded on: May 31, 2018
Description: Former FDA compliance officials Cynthia Schnedar and Howard Sklamberg discuss the Center for Drug Evaluation and Research’s plan for restructuring inspection and application review operations. Topics include:
- The new tone of interactions when approaching the agency on specific inspection and evaluation topics;
- What to expect from the FDA in conducting inspections and communicating results you need ASAP;
- New ways in which you’ll be able to encourage the FDA to meet commitments; and
- Difficulties facing the agency in implementing its new concept of operations.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Cynthia Schnedar, Executive VP-Regulatory Compliance, Greenleaf Health LLC; and Howard Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP
