2024 Workshops
NCRAF's 2024 workshop series is a comprehensive overview of regulatory requirements for development, manufacture, marketing and compliance for drug and biological human medicines and medical devices in the US, EU, and other countries. It is especially useful for those studying for the RAC certification exams in these areas, but also is valuable for anyone interested in learning more about WHY the industry operates as it does. Each session in the series features a lecturer with relevant industry or other "field" experience to illustrate the concepts discussed.
We have grouped the pre-recorded lectures into "chapters" of related topics, and will hold monthly (live via Zoom) Q/A sessions with a subset of the instructors from June through Sept. or October (2024). Each Q/A session will be focused on the topics covered in a different “chapter”.
Sessions will be by Zoom (only) and the Zoom link is in the registration confirmation email.
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PHARM/BIO
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2024 Chapter
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Speaker
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Topic
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Q/A Session for Chapter 1, Introduction: Tuesday, June 25, 7 -9 pm
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1 - Intro
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Maria Oyaski
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Introduction
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1 - Intro
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Kevin Barber
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Regulatory Authority Meetings
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1 - Intro
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Timothy Reinhardt
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CMC
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Q/A Session for Chapter 2, Early Development: Tuesday, July 30, 7 -9 pm
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2 - Early development
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Brenda Faiola
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Preclinical Development and GLPs
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2 - Early development
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Ben Vaughn,
Jamie Chang
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Clinical Protocols and Clinical Development Plans
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2 - Early development
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David Jensen
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Good Clinical Practice and Clinical Pharmacology/ Development
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2 - Early development
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Judy Hauser
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Combination Products
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Specific Q/A Session for Pharm/Bio Chapters 3 & 4: Tuesday, August 27, 7 -9 pm
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3 - Regulatory Procedures
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Karl Whitney
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INDs, IMPDs, CTAs, & CTXs
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3 - Regulatory Procedures
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Sheila Plant
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NDAs/BLAs, MAAs, JNDAs, NDSs
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3 - Regulatory Procedures
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Marissa Berry,
Nasrin Habibi
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Pediatric, Orphan Product and Expanded Access Development for Rare Diseases
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4 -Specific product types
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Catherine Maher
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Pharmaceuticals, Generics, and OTC Drugs
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4 -Specific product types
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Maria Oyaski
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Biologics and Biosimilars
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4 -Specific product types
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Maria Oyaski
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Advanced Medicinal Therapeutic Products
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Q/A Session for Chapter 5: Late Stage Development and Market Lifecycle: Tuesday, September 24, 7 -9 pm
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5 – Late development
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Lisa Hornick
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Pharmacovigilance and Risk Management
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5 – Late development
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Joseph Watson
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Prescription Product Labeling
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5 – Late development
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Drew Barlow
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Compliance, Regulatory Inspections, and Enforcement
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5 – Late development
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Karin McIntosh
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Post Marketing
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DEVICES
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2024 Chapter
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Speaker
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Topic
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Q/A Session for Chapter 1, Introduction: Tuesday, June 25, 7 -9 pm
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1 - Intro
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Maria Oyaski
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Introduction
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1 - Intro
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Kevin Barber
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Regulatory Authority Meetings
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1 - Intro
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Steve Burian
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CMC/Quality System Design & Development
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Q/A Session for Chapter 2, Early Development: Tuesday, July 30, 7 -9 pm
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2 - Early development
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Brenda Faiola
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Preclinical Development and GLPs
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2 - Early development
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Nicholas Kenny, Jack Modell, Ben Vaughn
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Clinical Protocols and Clinical Development Plans
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2 - Early development
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David Jensen
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Good Clinical Practices
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2 - Early development
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Judy Hauser
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Combination Products
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Specific Q/A Session for Medical Device Chapters 3 & 4: Tuesday, September 3,
7 -9 pm
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3 - Regulatory Procedures
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David Jensen
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IDEs, etc (ex-US device clinical trial submissions)
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3 - Regulatory Procedures
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Ken Butz
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510(k)s, PMAs, Canada, EU (CE mark, etc)
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3 - Regulatory Procedures
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Kevin Barber
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Special Programs (HDEs, Special Access, etc)
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4 -Specific product types
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Maria Oyaski
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Device Classification and Regulatory Controls
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4 -Specific product types
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Cheng Li
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Medical Device Design Process
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4 -Specific product types
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Maria Oyaski
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In Vitro Diagnostics, “LDTs”/CLIA, Companion Diagnostics
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4 -Specific product types
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Sheila Hemeon-Heyer
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Medical Device Software
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Q/A Session for Chapter 5: Late Stage Development and Market Lifecycle: Tuesday, September 24, 7 -9 pm
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5 – Late development
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Lisa Hornick
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Pharmacovigilance and Risk Management
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5 – Late development
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Theresa Scocca, Joseph Watson
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Prescription Product Labeling
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5 – Late development
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Drew Barlow
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Compliance, Regulatory Inspections, and Enforcement
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5 – Late development
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Karin McIntosh
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Post Marketing
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