Archived Meeting Presentations


Date Round
Speaker  Speaker Affiliation Topic Link to WebEx Recording
2023-04-25   Amanda Parrish & Nicoleta J Economou Duke University Algorithm-Based Clinical Decision Support (ABCDS) Oversight: A framework for the governance and evaluation of algorithms to be deployed at Duke Health


Slide Presentation

 2023-03-23    Rachel Capone  Syner-G Biopharma Group  An Overview of FDA Orphan Drug Designation


Slide Presentation

 2023-02-16    Kirsten Messmer, Senior Research Analyst  AgencyIQ  THE E.U. CLINICAL TRIALS

 Slide Presentation (No Recording)

 2202-11-16 15 Kevin B. Johnson, Chief Regulatory Officer  Ring Therapeutics  Storytelling, Hypnosis, and Vulcan Mind Melds:  The Art and Science of Persuasion in Regulatory Interactions  
 2202-11-16 14  Devin Rosenthal, VP  NovaQuest Capital Management  Regulatory Affairs Influence in Investment Decision-making  
 2202-11-16 13

Marissa Berry, Senior Manager of Regulatory Strategy,

Scott Kelly, President,

Hyloris Pharmaceuticals


Scott Kelly Consulting, Inc.
 The Logistics of Starting Your Own LLC/ Consulting Company  
 2202-11-16 12  Demetrius Carter, MBA, PMP, RAC-US, SVP Services Operations & Regulatory Services; Certara Synchrogenix;  Making the Switch: Transitioning your career into Regulatory Writing  
 2202-11-16 11 Mike Lance, Senior Regulatory Affairs Associate, CMC & Labeling United Therapeutics Corporation Premarket Safety Analysis with FDA Medical Queries (FMQs)  
 2202-11-16 10 Kirsten Messmer, PhD, RAC, Senior Research Analyst Agency IQ Advanced Therapies - Lessons learned from regulatory challenges  
 2202-11-16 7 Drusilla Scott, PhD, RAC, VP Regulatory Affairs Sobi, Inc. Manna from Heaven - It's PDUFA VII  
 2202-11-16 6 Cheng Li, PhD; Senior Principal Engineer Aerie Pharmaceuticals Combination Product Design Controls/QbD—Does it apply to you?  
 2202-11-16 4 Charles Jagun, Regulatory Senior Manager Merz Aesthetics Regulatory Intelligence – Medical Devices  
 2202-11-16 3 Cynthia Nolte, RAC, Director Regulatory Affairs
, Strategic Regulatory Service ICON, Plc. MDR/IVDR Technical Documentation Audits – War Stories from the Audit Trenches  
 2202-11-16 1  Clare Matti, Associate Director, Regulatory Affairs,  The FlexPro Group  EU Clinical Trial Regulation  
2022-04-28   J. Kaitlin Morrison UNC-Lineberger

Regulatory and Clinical Development Considerations for Chimeric Antigen Receptor (CAR) T cells

Recording (no slides)

2022-03-31   Lauren Seabrook Enzyvant Regulatory Affairs - Ag vs. Biotech; What's the difference?

Slide Presentation


2022-02-24   Amritha Kidiyoor Impact Pharmaceutical Services What's in a Name? Proprietary Naming of Drugs Slide Presentation (no recording)
2021-05-20    Edit Muhari-Stark  Biocryst Pharmaceuticals Regulatory Strategies in Global Pediatric Drug Development  
2021-03-18   David Jensen Duke University Limiting the Clinical Trial to What you Need  Slide Presentation (no recording)
 2021-02-18    Birgitta Hedin  Chiesi Group  Global Regulatory Strategies  
2020-12-03   Maria Oyaski Bavarian Nordic COVID Vaccine Development  
2020-11-18   Get Together   Picnic  
2020-09-17   Jim DiBiasi 3D Communications The Art of Effectively Managing Virtual Presentations and Meetings  
 2019-11-07        Roundtables  
 2019-10-17    David Shoemaker  Sr. VP R&D, Rho  US Legislation and Resulting Regulations: The Odd Couple  


  Steven Castillo

CEO Inpernum Pharma Consulting

Transitioning to a Career in Pharma Regulatory Affairs

Play recording (1 hr 9 min 17 sec)


Spring Symposium

  Dr. Kristen Buck

SVP, Chief Clinical Development for the Life Sciences, Optum

Accelerating Clinical Research by Leveraging EHR Data 

2019-04-18   Susan Watts, Ph.D.

 Global Regulatory Consulting Syneos Health

 Update on Pediatrics: US, Europe, Japan, China, and ICH  

Play recording (1 hr 0 min 2 sec)

2019-03-21   Pete Etchells Regulatory Affairs Professional Society  The RAC: Sector-Based RAC Exams and Your Career  

Play recording (1 hr 12 min 3 sec)

Recording password: (This recording does not require a password.)

2019-02-21   Kirsten Messmer, PhD, RAC PPD  CRISPR Babies - Scientific Progress or Ethical Nightmare?  
2018-12-13   Denise Sturdy, JD, RAC   Duke Clinical Research Institute   GDPR: What We (Think) We Know So Far

Post-presentation update and disclaimer  


Part 1

Streaming recording link:

Download recording link:


Part 2

Streaming recording link:

Download recording link:





Ernie Hood, Freelance Science Writer, Editor, and Podcast Producer



Wanda Wiley, Associate Director, Regulatory Affairs, Novella Clinical

Steve Gray, Regulatory Coordinator, Duke Cancer Institute

Emily Huddle, Regulatory Intelligence Manager, Gilead

 The Fast Track: Careers in Regulatory Science  
 2018-11-08 14   Will Lee, PhD, RAC,  Cato Research  Table 14: Best Practices for Preparing for FDA Meetings  
 2018-11-08 13   Kevin Healy, PhD, RAC  Enzyvant  Table 13: Gene Therapies and Advanced Tissue Therapies: FDA and EMA Pathways  
2018-11-08  12   Celine M. Clive  Polaris Compliance Consultants, Inc.  Table 12: How to Write a Good Audit Report  
2018-11-08  11   Sathya Ganesan PhD, RAC  G1 Therapeutics  Table 11: Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics  
2018-11-08  10 

 David Shoemaker, PhD

Kevin Barber, PhD

  Table 10: Right-to-Try or Right-to-Ask?  Understanding Right-to-Try and FDA’s Expanded Access   
2018-11-08   09  Cindy Nolte, PhD, RAC    Table 9: How is your company preparing for the MDR/IVR?  
2018-11-08  08  Tammy Carrea, MS, RAC   Baebies  Table 8: Artificial Intelligence in Medical Devices  
2018-11-08   07  Colleen Johns, RAC   Dova Pharmaceuticals.  Table 7: FDA Policy: Are the Incentives Right for Orphan Drugs?  
2018-11-08   07  Marian Rhodes, PhD, MS, RAC  UCB  Table 7: FDA Policy: Are the Incentives Right for Orphan Drugs?  
2018-11-08   05  Michelle Holbrook Thompson  FDA Quality and Regulatory Consulting   Table 5: Due Diligence in GxP Supplier Selection  
2018-11-08   04 Bert Regeer, MD  3D    Table 4:  CHMP Oral Explanations and FDA Advisory Committee Meetings – Understanding Similarities and Differences to Optimize Your Meetings  
2018-11-08  03  Kirsten Messmer, PhD, RAC   PPD  Table 3: Regulatory Intelligence – Building Strategies for Drug Development in the Changing Regulatory Landscape  
2018-11-08  02   Maria Oyaski (MS, MA, RAC (US, EU) Face Life Sciences  Table 2: How to Kill Your Biotech Startup  


Round Table Event Dinner

 01 Kylie Opel JD Duke Clinical Research Institute, 


Table 1: GDPR and the New World of Data Privacy


Dana Minnick, Senior Research Scientist


Scott Burian, Senior Research Scientist

Rho, Inc.   Bench to Clinic: Preparing for a Successful Translation  
 2018-05-16    Dr. Ben Yerxa CEO at Foundation Fighting Blindness 

 Spring Symposium

The Wild Ride of Biotech:

Startups, Spinouts, IPOs, and Nonprofits  


Panelists:    Susan Nichols, CEO, Falcon Therapeutics & Richard Smith, COO, StrideBio


Moderator:  Ed Field, President, BioLabs NC

 CEO at Foundation Fighting Blindness  Business Strategies and Regulatory Challenges for Early Stage Companies - A Panel Discussion  
 2018-03-22    Michelle Thompson  

FDA Quality and Regulatory Consultants LLC

 Risk-based Decision Making  
 2018-02-22    Tammy Carrea Vice President, Quality & Regulatory
Navigating a Panel Review - 
FDA Advisory Committee Approval of a De Novo Medical Device
2018-01-18    Yuan Xu  Focus 42 Change Control Best Practice Deciding When to Submit a 510(k) for a Device Change  
2017-12-14        RAPS Webinar: PDUFA VI  
2017-11-09 01  Sathya Ganesan  Manager in Regulatory Affairs at PPD Development  Table 1: Global perspective on orphan drug regulations - compare/contrast process in US, EMA, Australia, and Japan  
2017-11-09 02  Bhargavi Rao  Regulatory Affairs lead, PPD  EU CT Regulations  
2017-11-09 03  Greg Hileman   Senior Regulatory Scientist and Strategy Advisor for Cato research  Getting Started: Requirements for First time in Human Studies  
2017-11-09 04  Kirsten Messmer  Principal Regulatory Affairs Specialist in the Regulatory Intelligence Solutions team at PPD  CAR-T Cells – Development and Approval Play-by-Play  
2017-11-09 05  Kevin Healy  Roivant  Regulatory Innovation and the RMAT Designation  
2017-11-09 06  Jim DiBiasi  3D Communications  Communicating Benefit-Risk is Fundamental to Device Approval and Market Adoption  
2017-11-09 07  Don Alexander    Seeking Yes. Effective communications in job search and beyond  
2017-11-09 08  Maria Oyaski  Regulatory Affairs Director, Metabolon  Privacy Please!  Data privacy rules for medicine and research in the US and the EU  
2017-11-09 09  Drusilla Scott  Vice-President, Regulatory Affairs, at BioDelivery Sciences  What’s in the Mix for PDUFA VI?  
2017-11-09 10  Nicole Baker  Manager, Global Regulatory Affairs, Roivant  Leveraging Real World Evidence in Regulatory Approvals  
2017-11-09 11  Margaret Schubert  Regulatory Operations group at Cato Research  eCTD - What’s the Big Deal  
2017-11-09 13  Kelly Roney    Priority Review Vouchers  
2017-11-09 14  Rudy Fuentes  Regulatory Affairs Manager at QuintilesIMS  IND Submissions: Past, Present, and Future  
 2017-11-09 15  Joan Drucker  Vice President and Head of the Infectious Diseases and Vaccines Center of Excellence, IQVIA  5 Years after GAIN: QIDP Progress  
2017-10-19    Kelly Roney, Brant Hamel, Matt Medlin, Lakshmi Venkatakrishnaiah    RAPS Regulatory Convergence Roundup  
2017-09-21    Charity Schuller, Sheila Plant, Marian Rhodes    Starting Your Regulatory Affairs Career  
2017-05-17    Robert Califf, MD  Former FDA Commissioner  A Sit-down Talk with Former FDA Commissioner Dr. Robert Califf  
 2017-04   Catherine Carlisle Leonard  3D Communications  FDA Advisory Committes 101: The Basics

 Webinar Link:

 Slides HERE

 2016-10    Bob Rohde, Susan Sisk    Out-of-(CSR)-Body Experiences-Tips on Assembling Appendices, Datasets, and CRFs  


SLIDES-ROHDE LINK:   assets/Education/csr dataset-crfs-refs-final-br-10-16-2016-handout.pdf

SLIDES-SKSK LINK: assets/Education/csr appendices-datasets-crfs-2016-10-10-notes-bw.pdf


 2016-09   Suneela Thatte, VP, Global Operations  Quintiles India Regulatory Turnaround makes India an Increasingly Attractive Location for Clinical Research  WEBINAR LINK:
2016-05   Carla Balch  President, NantCare and NantCRO  A Regulatory Overview of Cancer MoonShot2020  
2016-04   Susan Bostian, MURP, PE Duncklee & Dunham’s Environmental Regulatory Compliance team Environmental Regulations for Destruction of Investigation Products  
2016-03-10   Jane Horvath 3D Communications

Truth & Consequences: Pricing, Patient Access and What's Next for Today's BioPharm

2016-02-18   Kirsten Messmer and Charity Metz Schuller

Senior RA Specialist, Regulatory Intelligence Solutions; and Director, Regulatory Affairs, PPDI

"Regulatory Intelligence" - Building Strategies for Drug Development


SLIDES: assets/Education/2016-02-18-regulatory_intelligence_in_drug_development.pdf


2016-01-28   Rebecca Carson Rogers Chairperson, Schulman IRB

"Orphan Devices" - Humanitarian Use Device (HUD) Exemptions

2015-11-12 01 Brian McMerty President, Carlyle Conlan

Career Development

2015-11-12 02 Poonam Pande President, Integrated CMC Solutions

cGMPs and inspections: Overview from FDA's recent SBIA meeting

2015-11-12 03 Kevin Healy Senior Director of Regulatory Affairs, Mallinckrodt Pharmaceuticals

Bio Like Me: Recent Events & Current Hot Topics with Biosimilars

2015-11-12 04 Drusilla Scott Senior Vice-President, Regulatory Affairs,Cempra Pharmaceuticals

The End of Alphabet Soup – The Pregnancy and Lactation Labeling Rule

2015-11-12 05 Evan Richardson Director, Regulatory Submissions, GlobalSubmit, Inc.

Making a List and Checking it Twice: Using Checklists to Ensure High Quality Regulatory Submissions.

2015-11-12 06 BJ Witkin

Regulatory Publishing Manager, Impact Pharmaceutical Services

Who's on First?  The new Module 1  
2015-11-12 07 Elvis Osei-Tutu Post-doctoral Fellow, GlaxoSmithKline

Name that Drug! How pharma companies name their assets

2015-11-12 08 Kirsten Messmer and Charity Metz Schuller

Senior RA Specialist, Regulatory Intelligence Solutions; and Director, Regulatory Affairs, PPDI

Regulatory Intelligence - Building Strategies for Drug Development  
2015-11-12 09 Larry Hofmann Managing Director, LMH Associates

pre-IND 12-step: Recipe for IND filing success

2015-11-12 10 Valerie Amspacher ORISE Fellow, FDA

Growing Pains - Making Pediatric clinical trials  better!

2015-11-12 11 Cynthia Nolte Director, Regulatory Affairs, ICON PLC

Integration of human factors engineering into medical device development

2015-11-12 13 Sandra Boyd Staff Associate, Biogen Idec

Split Personalities: Combination Products

2015-11-12 14 H Eiichi  Sengoku Manager, Diagnostics and Devices in Global Regulatory Affairs;  GlaxoSmithKline

Diagnostics across borders: Key differences of IVD regulations in the EU vs US

2015-11-12 15 Matt Medlin Manager, US Regulatory Affairs R&D Pipeline;  CHIESI USA, INC.

FDA’s Golden Tickets: Priority Review Vouchers for Rare Pediatric and Tropical Disease Drugs

2015-11-12 16 Jennifer Moen

Principal Clinical Research Scientist and Associate Director of Corporate Communications, Impact Pharmaceutical Services, Inc.

Medical Writing for Regulatory Affairs Professionals  
2015-10-15   Jay Campbell Executive Director, North Carolina Board of Pharmacy

Regulation of Pharmacy Compounding After NECC:  Opportunities and Challenges

2015-09-17   Mike Hinckle Partner at K&L Gates LLP

Expanded Access - Tough Choices and Unintended Consequences

2015-06-11   David Shoemaker Senior Vice President, R&D, Rho, Inc.

Regulatory Decision Making in Integrated Product Development 

2015-04-16   BJ Witkin Regulatory Publishing Manager, Impact Pharmaceutical Services

Electronic Publishing for Paper People: Things your publisher wishes she could tell you

2015-03-19   Mike Benecky Senior Director, Global Regulatory Affairs in Diagnostics, GlaxoSmithKline

Regulation of Companion Diagnostic Tests and FDA’s Proposed Regulatory Framework for Laboratory Developed Tests

2015-01-15   Erin O'Reilly

Associate Director Regulatory Affairs, Duke Translational Medicine Institute, Duke University

Mobile Apps as Medical Devices  
2014-11-13 01 Don Alexander

Practice Head and VP, Life Sciences (Carlyle Conlan)

Regulatory Affairs Profession  
2014-11-13 02 Celine Clive President (Polaris Compliance Consultants)

Risk based monitoring vs. Risk based auditing

2014-11-13 03 Jingwen Chen Global GMO Detection Lead (Syngenta Biotechnology)

Plant biotechnology product development, safety evaluation and regulatory approval

2014-11-13 04 I.M. Grossi (gina) Director of Toxicology (Chimerix)

GLP and Data Quality in Containment:  Studies Conducted Under The Animal Rule

2014-11-13 05 Denise Sturdy Regulatory Associate, Regulatory Intelligence (DCRI)

Sling back shoes and the changing landscape of clinical trial applications in the EU: what’s in store under Regulation (EU)536/2014

2014-11-13 06 Amy Blawas Associate Director of Pharmaceutical Development (Cato Research)

What's Mine is Mine, and What's Yours is Yours (DMFs)

2014-11-13 07 David Jensen Regulatory Associate, Investigational Applications (DCRI)

Unapproved Drugs Available at a Pharmacy Near You!

2014-11-13 08 Tammy Carrea President/CEO (RegMatters LLC)

FDA's recent changes to the substantial equivalence decision making process for 510(k)s

2014-11-13 09 Diya Abdeljabbar Senior Engineering Specialist, Upstream Process Analytics, Merck & Company Global Vaccine Supply & Regulation  
2014-11-13 10 BJ Witkin Regulatory Publishing Manager, Impact Pharmaceutical Services

BioCryst's NDA for Peramivir: regulatory & publishing challenges

2014-11-13 11 Emily Huddle

Regulatory Intelligence Executive - US (GlaxoSmithKline)

Regulatory Intelligence  
2014-11-13 12 Kevin Healy Director, Regulatory Affairs (Mallinckrodt Pharmaceuticals)

Breakthrough Therapies and Expedited Programs

2014-11-13 13 Susan Sisk Principal Consultant (spf Consulting)

Writing the CSR Synopsis: Reduce, Recycle, Reuse

2014-11-13 14 Nancy Chew

Principal Consultant (Regulatory Affairs North America)

Help! I need an IND!  
2014-11-13 15 Joseph Knight-McKenna

Director, Knowledge and Quality Management, Global Data and Safety Monitoring (Quintiles)

Inspection Readiness  
2014-10-16   Kamali Chance

Sr. Director; Head, Global Biosimilars Regulatory Strategy, Quintiles

Biosimilars in the US  
2014-09-18   Amanda Parrish and Erin O'Reilly

Associate Directors Regulatory Affairs, Duke Translational Medicine Institute, Duke University

Discussions with CDRH about Pre-Market Device Issues and clinical Research  
2014-05-01   Robert M. Califf, MD Vice Chancellor of Clinical and Translational Research, Director of the Duke Translational Medicine Institute (DTMI), and Professor of medicine in the Division of Cardiology at the Duke University Medical Center. Disrupting the Clinical Research Fabric in the US  
2014-04-17   Susan Watts

Director, Therapeutic Group, Global Regulatory Affairs at GlaxoSmithKline

PREA Compliance, PSPs under FDASIA

2014-03-20   Dana Minnick, Anita Woodring, and David Houck Drug Development Project Manager, Global Health Technologies, RTI International; Regulatory project leader, RTI International; and President, Pharmakey LLC Pre-IND Drug Development  
2014-02-16   Drusilla Scott Senior Vice-President, Regulatory Affairs,Cempra Pharmaceuticals

Follow the Yellow Brick Road - Special Regulatory Pathways for Drugs and Biologics in the US

2014-01-17   Larry Hofmann Managing Director, LMH Associates

The Pre-IND Program: 12 Steps to a successful IND filing

2013-11 01 Susan Watts  

New FDA Guidances for 2013

2013-11 02 Matt Medlin  

Sunshine Act Uncertainties

2013-11 03 Rachel Hardy  

From Crisis to Legislation to Regulation: The compounding pharmacy case

2013-11 04 Michael Hinkle  

Affordable Care Act’s Medical Device Excise Tax.

2013-11 05 Maria Oyaski  

Breakthrough Therapies - Are we fabulous enough yet?

2013-11 06 Lorna Dula Results Reporting… It’s Not A Choice Anymore! 

2013-11 07 Linda Charles  

If I only knew then what I know now...or how to plan for your first CE mark EU Technical File. 

2013-11 08 Diane Wold  

Submission of Datasets using CDISC Standards

2013-11 09 Brooke Moody  

SOPs, Training and Auditing

2013-11 10 Don Alexander  

Regulatory Affairs Careers

2013-11 11 Cari Newton and Jamie Blackburn

Preparing for a Successful FDA Advisory Committee or Device Panel Meeting

2013-10-17   Allison L. St. John  

GLP and GMP in the Field of Biodefense

2013-09-19   Lisa Olson  

Electronic Records are Not My Responsibility - Guess Again!

2013-05-09   Brett Weed State Liaison, FDA-Atlanta District

Stories from the Sandbox: Regulatory Integration and Parallel Play

2013-04-18   Ken Edds  

What to Expect during an FDA Audit

2013-03-21   Tamara Pinkett  

A Statistician’s Perspective of Traditional Phase II and Phase III Drug Development

2013-02-21   Linda Charles and Maria Oyaski

Update on DSURs and approach for large and small companies

2012-11 01 Susan Zecchini  

 Advertising and promotion review. FDA Hot Buttons.

2012-11 02 Nancy Chew  

PreIND/IND Wonder Submissions: Your Bread and Butter.

2012-11 03 Michele Pruett  

Working in the Twilight Zone: "GMP" and quality elements for non-regulated R&D Labs

2012-11 04 Dana Minnick  

 ICH M7: Qualification of impurities and everything else in that goop you call a drug.

2012-11 06 Erin O'Reilly Registrations. Big Brother wants your data

2012-11 07 Celine Clive  

Risk Based Monitoring: Sanity returned or cheap trials?

2012-11 08 Drusilla Scott  

PDUFA V: Get with "The Program"!

2012-11 09 Aida Cancel  

 Clinical Trials and Product Registrations in Emerging Regions.

2012-11 10 Don Alexander  

Regulatory Affairs Careers. Get One.

2012-11 11 Ken Edds  

Hey! I'm talking here! Device Pre-Sumission discussions and meetings with FDA.

2012-10-04   Jason Rock Chief Technology Officer, GlobalSubmit Regulated Product Submissions (RPS)  
2012-09-13   RAPS Webinar  

Strategies for your Career:  Finding YOUR Pathway into Regulatory Affairs

2012-05-03   Pierre Leveau and Decebal Bora Head of the Quality Safety & Environment Unit at the European Directorate for the Quality of Medicines & HealthCare (EDQM); Director of Regulatory Affairs, ActoGeniX Biologicals in Europe, regulatory aspects and new developments  
2012-04-19   Drusilla Scott Senior Vice President of Regulatory Affairs, Cempra Pharmaceuticals What's New in Orphan Drugs  
2012-03-14   David Shoemaker Sr. Vice President, Research and Development, Rho, Inc.

PDUFA V: Possibilities and Practical Expectations

2012-02-16   Amy Kniefel Director Regulatory Affairs, AptivSolutions

eCTD Friendly Module 3: Considerations on How to Write an NDA Chemistry Section

2012-01-25   Neil Armstrong CEO MeddiQuest Limited

Recasting EU Medical Device Directives: Reasons, Rationale And Predictions

2011-11 01 Susan Watts and Don Kafader   Companion Diagnostics  
2011-11 02 Joe Knight-McKenna   Quality Risk Management  
2011-11 03 Karteek Sandadi  

Challenges in Migrating eCTDs from Multiple Tools and Format

2011-11 04 Nancy Chew  

Pre-IND/IND free-for-all

2011-11 05 Cari Newton 3D Communications

Advisory Committee Meetings: The Steps to a Successful FDA Advisory Committee

2011-11 06 Jeff Sorbel  

Adaptive Clinical Trial Designs

2011-11 07 Rebecca Sagosz  

Regulatory Intelligence

2011-11 08 Bob Kunka  

Pediatrics / consent

2011-11 09 Jeff Abolafia  


2011-11 10 Maria Oyaski  

Special Protocol Assessment

2011-11 11 Ken Edds  

Medical Devices

2011-11 12 Don Alexander  

Regulatory Careers




ExComm MtgMin Feb2013

Annual Round Table 2012 Topics







Agency IQ