| Date |
Round
Table |
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 |
Recording
Slide Presentation
|
| 2023-03-23 |
|
Rachel Capone |
Syner-G Biopharma Group |
An Overview of FDA Orphan Drug Designation |
Recording
Slide Presentation
|
| 2023-02-16 |
|
Kirsten Messmer, Senior Research Analyst |
AgencyIQ |
THE E.U. CLINICAL TRIALS
REGULATION IMPLEMENTATION |
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
Recording
|
| 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 |
|
|
2019-09-19
|
|
Steven Castillo |
CEO Inpernum Pharma Consulting
|
Transitioning to a Career in Pharma Regulatory Affairs
|
Play recording (1 hr 9 min 17 sec) |
|
2019-05-09
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 |
|
| 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:
|
|
|
|
| 2018-11-15 |
|
Moderator:
Ernie Hood, Freelance Science Writer, Editor, and Podcast Producer
Panelists:
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 |
|
|
2018-11-08
Round Table Event Dinner
|
01 |
Kylie Opel JD |
Duke Clinical Research Institute, |
Table 1: GDPR and the New World of Data Privacy
|
|
| 2018-09-20 |
|
Dana Minnick, Senior Research Scientist
and
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
|
|
| 2018-04-26 |
|
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
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 |
|
|
|
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: https://quintilesconferencing.webex.com/quintilesconferencing/ldr.php?RCID=8eca0f537589550f9e88a98185e6d4bb
Slides HERE
|
| 2016-10 |
|
Bob Rohde, Susan Sisk |
|
Out-of-(CSR)-Body Experiences-Tips on Assembling Appendices, Datasets, and CRFs |
WEBINAR LINK: https://quintilesconferencing.webex.com/quintilesconferencing/ldr.php?RCID=fa848ab092261d9ed31496f9317e328f
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: https://quintilesconferencing.webex.com/quintilesconferencing/ldr.php?RCID=fa848ab092261d9ed31496f9317e328f |
| 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 |
WEBEX: https://quintilesconferencing.webex.com/quintilesconferencing/ldr.php?RCID=45f83246508a3513104de22017656d7f
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 |
|
ClinicalTrials.gov 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 |
|
ClinicalTrials.gov 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 |
|
CDISC
|
|
| 2011-11 |
10 |
Maria Oyaski |
|
Special Protocol Assessment
|
|
| 2011-11 |
11 |
Ken Edds |
|
Medical Devices
|
|
| 2011-11 |
12 |
Don Alexander |
|
Regulatory Careers
|
|
