2024 Workshops
We have grouped the lectures into "chapters" of related topics, and will hold monthly (live via Zoom) Q/A sessions with a subset of the instructors. 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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