List of Prior NCRAF Meeting Presentations

Date Speaker  Speaker Affiliation Topic
2024-05-20 Susan Neadle Combination Products Consulting Services LLC Spring Symposium _ Regulatory Strategy for Drug-Led Combination Products
2024-04-24 Carmen Amador The LaSalle Group Lessons Learned: Effective Inspection Readiness Program
2024-03-26 RJ Wirth and Rikki Mangrum Vector Psychometric Group Measuring What Matters to Patients
2024-02-29 Merrie Mosedale UCB Review of Key FDA (CDER) Activities in 2023
2024-02-15 Kirsten Messmer AgencyIQ New Year, New EU Pharmaceutical Legislations?
2023-11-09 12 speakers/topics various 2023 ROUNDTABLE DINNER
2023-10-26 Cheng Li and Shauna Swanson  Alcon and Stemline Therapeutics Applying Human Factors Engineering to Drug Development
2023-09 Moderator: Demetrius Carter (Synchrogenix) Panelists: Kim Jochman (Merck); Sam Suarez (Abbvie); Seth D. DePuy (Premier Consulting); and Rebekah Schulz (Parexel) Crafting Careers: The Synergy between Medical Writing and Regulatory Affairs
(Joint presentation with AMWA)
2023-05-30 through 2023-09-26 multiple multiple NCRAF 2023 Pharma/Biologics Workshop Series
2023-06-01 Linda Bowen Seagen 2023 SPRING SYMPOSIUM_ Opportunities and Challenges: Pilots and Projects in the Oncology Center of Excellence
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
2023-03-23  Rachel Capone  Syner-G Biopharma Group  An Overview of FDA Orphan Drug Designation
 2023-02-16  Kirsten Messmer  AgencyIQ The EU Clinical Trials Regulation Implementation  
2022-11-16 9 speakers/topics various 2022 ROUNDTABLE DINNER
2022-06-07 through 2022-09-27 multiple multiple NCRAF 2022 Pharma/Biologics Workshop Series  and  Medical Devices Workshop Series
2022-04-28 J. Kaitlin Morrison UNC-Lineberger Regulatory and Clinical Development Considerations for Chimeric Antigen Receptor (CAR) T cells
2022-03-31 Lauren Seabrook Enzyvant Regulatory Affairs - Ag vs. Biotech; What's the difference?
2022-02-24 Amritha Kidiyoor Impact Pharmaceutical Services What's in a Name? Proprietary Naming of Drugs
2021-10-10 NCRAF members all Family Day at NC Museum of Life and Sciences
2021-06-01 through 2021-09-28 multiple multiple NCRAF 2021 Pharma/Biologics Workshop Series  and  Medical Devices Workshop Series
2021-05-20  Edit Muhari-Stark  Biocryst Pharmaceuticals Regulatory Strategies in Global Pediatric Drug Development
2021-04-22 Alex Gaffney, Kirsten Messmer, Laura DiAngelo POLITICO Agency IQ FDA and the pandemic: What’s next, and what’s here to stay
2021-03-18 David Jensen Duke University Limiting the Clinical Trial to What you Need
2021-02-18  Birgitta Hedin Chiesi Group Global Regulatory Strategies
2020-12-03 Maria Oyaski Bavarian Nordic COVID Vaccine Development
2020-10-18 NCRAF members all Outdoor Picnic / Get-together
2020-09-17 Jim DiBiasi 3D Communications The Art of Effectively Managing Virtual Presentations and Meetings
2020-06-02 through 2020-09-29 multiple multiple NCRAF 2020 Pharma/Biologics Workshop Series  and  Medical Devices Workshop Series
2020-05-21 Edie Williams, Connie Cwik Edie Williams and Cwik Business Connections Developing High Performance Teams that Attract, Develop and Retain Talent
2020-03-19 Clare Matti NCRAF BREXIT – What to Expect for Medical Products
2020-02-13 Will Lee Cato IND Submission Lessons Learned
2020-01-16 Carrie-Lynn Langlais Furr Bacteriophage & Drug Development Consultants Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD)
2019-12-13 Sathya Ganesan G1 Therapeutics Developing a Draft Package Insert
2019-11-07 12 speakers/topics various 2019 ROUNDTABLE DINNER
2019-10-17  David Shoemaker  Rho  US Legislation and Resulting Regulations: The Odd Couple
2019-09-19 Steven Castillo Inpernum Pharma Consulting Transitioning to a Career in Pharma Regulatory Affairs
2019-06-04 through 2019-09-24 multiple multiple NCRAF 2019 RAC(US) Workshop Series
2019-05-09 Kristen Buck Optum 2019 SPRING SYMPOSIUM_Accelerating Clinical Research by Leveraging EHR Data
2019-04-18 Susan Watts Syneos Health Update on Pediatrics: US, Europe, Japan, China, and ICH
2019-03-21 Pete Etchells Regulatory Affairs Professional Society  The RAC: Sector-Based RAC Exams and Your Career
2019-02-21 Kirsten Messmer PPD CRISPR Babies - Scientific Progress or Ethical Nightmare?
2018-12-13 Denise Sturdy Duke Clinical Research Institute   GDPR: What We (Think) We Know So Far
2018-11-15 Moderator:Ernie Hood   Panelists:  Wanda Wiley (Novella Clinical); Steve Gray (Duke Cancer Institute);
Emily Huddle (Gilead)
The Fast Track: Careers in Regulatory Science
2018-11-08 14 speakers/topics various 2018 ROUNDTABLE DINNER
2018-09-20 Dani Minnick and Scott Burian Rho Bench to Clinic: Preparing for a Successful Translation
2018-06-05 through 2018-09-25 multiple multiple NCRAF 2018 RAC(US) Workshop Series
2018-05-16 Ben Yerxa Foundation Fighting Blindness 2018 SPRING SYMPOSIUM_The Wild Ride of Biotech: Startups, Spinouts, IPOs, and Nonprofits
2018-04-26 Moderator:  Ed Field (BioLabs NC) Panelists:  Susan Nichols (Falcon Therapeutics) & Richard Smith (StrideBio) Business Strategies and Regulatory Challenges for Early Stage Companies - A Panel Discussion
2018-03-22 Michelle Thompson FDA Quality and Regulatory Consultants Risk-Based Decision-Making
2018-02-22  Tammy Carrea Baebies  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 Eileen Fein and Allison May Rosen 3D Communications RAPS Webinar: PDUFA VI (Patient Voice in the Approval and Value Process)
2017-11-09 14 speakers/topics various 2017 ROUNDTABLE DINNER
2017-10-19 Kelly Roney, Brant Hamel, Matt Medlin, Lakshmi Venkatakrishnaiah   RAPS Regulatory Convergence Roundup
2017-09-21 Charity Schuller, Sheila Plant, Marian Rhodes PPD, Cato, QuintilesIMS Starting Your Regulatory Affairs Career
2017-06-06 through 2017-09-26 multiple multiple NCRAF 2017 RAC(US) Workshop Series
2017-05-17 Robert Califf Former FDA Commissioner Spring Symposium_A Sit-down Talk with Former FDA Commissioner Dr. Robert Califf
2017-04-20 Catherine Carlisle Leonard 3D Communications FDA Advisory Committees 101: The Basics
2017-03-16 Kirsten Messmer and Charity Schuller PPD Demystifying US Biosimilars
2017-02-16 Paul Vick and Denise Sturdy Duke Health and DCRI 21st Century Cures Act - the ambition and the reality
2017-02 Clare Matti, Denise Sturdy, et al multiple NCRAF 2017 RAC(EU) Workshop Series
2016-11-09 13 speakers/topics various 2016 ROUNDTABLE DINNER
2016-10 Bob Rohde, Susan Sisk   Out-of-(CSR)-Body Experiences-Tips on Assembling Appendices, Datasets, and CRFs
2016-09 Suneela Thatte Quintiles India Regulatory Turnaround makes India an Increasingly Attractive Location for Clinical Research
2016-06-07 through 2016-09-27 multiple multiple NCRAF 2016 RAC(US) Workshop Series
2016-05 Carla Balch NantCare and NantCRO Spring Symposium_A Regulatory Overview of Cancer MoonShot2020
2016-04 Susan Bostian Duncklee & Dunham 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 Schuller PPD "Regulatory Intelligence" - Building Strategies for Drug Development
2016-02-23 Stefan Burde BSI Healthcare EU IVD regulation – current status and upcoming changes
2016-01 Clare Matti, Denise Sturdy, et al multiple NCRAF 2016 RAC(EU) Workshop Series (dates approx.)
2016-01-28 Rebecca Carson Rogers Schulman IRB "Orphan Devices" - Humanitarian Use Device (HUD) Exemptions
2015-12-09 eCTD group various Holiday Lunch
2015-11-12 16 speakers/topics various 2015 ROUNDTABLE DINNER
2015-10-15 Jay Campbell North Carolina Board of Pharmacy Regulation of Pharmacy Compounding After NECC:  Opportunities and Challenges
2015-10-14 Bob Rohde, Evan Richardson, and Martin Wileman   eCTD group meeting_ Preparing for an NDA – The Publisher’s Perspective
2015-09-17 Mike Hinckle K&L Gates LLP Expanded Access - Tough Choices and Unintended Consequences
2015-09-09 eCTD group Open panel discussion ECTD Meeting-Stump the Chumps
2015-06-11 David Shoemaker Rho Spring Symposium_Regulatory Decision Making in Integrated Product Development
2015-06-02 through 2015-09-29 multiple multiple NCRAF 2015 RAC(US) Workshop Series
2015-04-16 BJ Witkin Impact Pharmaceutical Services Electronic Publishing for Paper People
(Things your publisher wishes she could tell you)
2015-03 Clare Matti, Denise Sturdy, et al multiple NCRAF 2015 RAC(Canada) Workshop Series
2015-03-19 Mike Benecky GSK Regulation of Companion Diagnostic Tests and FDA’s Proposed Regulatory Framework for Laboratory Developed Tests
2015-02-11 Bob Rohde, Evan Richardson, and BJ Witkin Bob Rohde, BioVentus, and Impact Pharma eCTD group_PDF Toolbox Comparisons
2015-01-15 Erin O’Reilly Duke Translational Medicine Institute, Duke University Mobile Apps as Medical Devices
2015-01 Clare Matti, Denise Sturdy, et al multiple NCRAF 2015 RAC(EU) Workshop Series
2014-11-13 15 speakers/topics various 2014 ROUNDTABLE DINNER
2014-11-12 Martin Wileman BioCryst eCTD Group_Feedback from conference attendance including EDM of Sept. 22-24
2014-10-16 Kamali Chance Quintiles Development of Biosimilars in the US
2014-10-08 Kelly Hibbard and Evan Richardson -- eCTD Group_SPL (structured product labeling);History, what’s involved, what it looks like when it’s done
2014-09-23 Julie Omohundro -- Networking Lunch_Globalization of Regulatory Affairs
2014-09-18 Amanda Parrish and Erin O'Reilly Duke Translational Medicine Institute, Duke University Discussions with CDRH about Pre-Market Device Issues and clinical Research
2014-06-03 through 2014-09-30 multiple multiple NCRAF 2014 RAC(US) Workshop Series
2014-05-01 Robert Califf Duke Translational Medicine Institute (DTMI) SPRING SYMPOSIUM_Disrupting the Clinical Research Fabric in the US
2014-04-17 Susan Watts GSK PREA Compliance, Pediatric Study Plans under FDASIA
2014-03-20 Dana Minnick, Anita Woodring, and David Houck RTI International and Pharmakey Pre-IND Drug Development
2014-03-12 Kathy Elks and Don Alexander Impact Pharma and Carlyle/Conlan eCTD Group_Results of the ECTD Professional Survey that was conducted in the Fall of 2013 <and> Trends and Employment Dynamics in the Industry
2014-02-16 Drusilla Scott Cempra Pharmaceuticals Follow the Yellow Brick Road - Special Regulatory Pathways for Drugs and Biologics in the US
2014-01-17 Larry Hoffman LMH Associates The Pre-IND Program: 12 Steps to a successful IND filing
2014-01 Clare Matti, Denise Sturdy, et al multiple NCRAF 2014 RAC(EU) Workshop Series
2013-11-21 Linda Karolak -- Networking Lunch_Regulations Affecting Clinical Research Associates
2013-11-14 11 speakers/topics various 2013 ROUNDTABLE DINNER
2013-10-22 Laurin Mancour Athenium Consulting Networking Lunch_Career Development in Regulatory Affairs
2013-10-17 Alison St. John US Department of Defense GLP and GMP in the Field of Biodefense
2013-09-19 Lisa Olson PAREXEL Electronic Records are Not My Responsibility...Guess Again!
2013-09-17 David Jensen Duke Clinical Research Institute Networking Lunch_Regulatory Aspects of Conducting NIH Sponsored Research
2013-08-28 Mary K D’Rozario CRP Link Networking Lunch_Regulatory Issues Related to Social Media
2013-06-27 April Mayberry   Networking Lunch_Regulatory Affairs & Contraceptive Development
2013-06-04 through 2013-09-17 multiple multiple NCRAF 2013 RAC(US) Workshop Series
2013-05-09 Brett Week FDA-Atlanta District SPRING SYMPOSIUM_Stories from the Sandbox: Regulatory Integration and Parallel Play
2013-04-25 Bob Rhode   Networking Lunch_ IND/eCTD Issues and Options
2013-04-18 Ken Edds Kenneth Edds Associates What to Expect during an FDA Audit
2013-03-28 NCRAF members __ Networking Lunch_Lunchers Choice: The Participants Decide What to Discuss
2013-03 Clare Matti, Denise Sturdy, et al multiple NCRAF 2013 RAC(Canada) Workshop Series
2013-03-21 Tamara Pinkett Quintiles A Statistician’s Perspective of Traditional Phase II and Phase III Drug Development
2013-02-21 Linda Charles and Maria Oyaski Grifols_small-company experience Update on DSURs and approach for large and small companies
2013-02-19 Wanda Wiley __ Networking Lunch_Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions –Including the Statement of Investigator (Form FDA 1572) May 2010 version
2013-01-23 Clare Matti and Alex McCormick DCRI Networking Lunch_Preparing for the RAC (Regulatory Affairs Certification)
2012-12-13 Robb Giddings   Networking Lunch_Deriving Maximum Value from an Overhead Function: The Role of the Legal Department in Clinical Development
2012-11-08 11 speakers/topics various 2012 ROUNDTABLE DINNER
2012-10-04 Jason Rock Global Submit Regulated Product Submissions (RPS)
2012-09-13 RAPS Webinar _ Strategies for your Career:  Finding YOUR Pathway into Regulatory Affairs
2012-09-13 Laurin Mancour _ Networking Lunch_Career Development in Regulatory Affairs
2012-09-12 Linda Charles and Maria Oyaski _ eCTD Group_DSUR's (Developmental Safety Update Reports)
2012-08-28 April Mayberry _ Networking Lunch_Regulatory Current Events
2012-06-21 Lisa Sanders _ Networking Lunch_A Moderated Discussion of International Regulatory Submissions
2012-05-03 Pierre Leveau and Decebal Bora European Directorate for the Quality of Medicines & HealthCare (EDQM); ActoGeniX SPRING SYMPOSIUM_Biologicals in Europe, regulatory aspects and new developments
2012-04-19 Drusilla Scott Cempra Pharmaceuticals What's New in Orphan Drugs
2012-04-18 Lisa Olsen _ Networking Lunch_Part 11 – Why you need to know
2012-03-20 April Mayberry _ Networking Lunch_”To Say or Not to Say?”
2012-03-14 David Shoemaker Rho PDUFA V: Possibilities and Practical Expectations
2012-02-16 Amy Kniefel AptivSolutons eCTD Friendly Module 3: Considerations on How to Write an NDA Chemistry Section
2012-01-25 Neil Armstrong MeddiQuest Recasting EU Medical Device Directives: Reasons, Rationale And Predictions
2011-11-xx 12 speakers/topics various 2011 ROUNDTABLE DINNER