www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
Regulatory Education for Industry (REdI) Annual Conference
July 19 - 23, 2021
Webcast
Activity Coordinator:
Lisa Misevicz (lisa.misevicz@fda.hhs.gov),  Carolina Reese (Carolina.Reese@fda.hhs.gov),  Rachel Kichline (Rachel.Kichline@fda.hhs.gov),  Larissa Lapteva (Larissa.Lapteva@fda.hhs.gov),  Elias Mallis (Elias.Mallis@fda.hhs.gov)
 
Description

This course is designed to provide participants with a strong, basic foundation in understanding the FDA's drug, biologic and medical device regulatory requirements. Presentations include Q&A sessions with subject matter experts from CDER, CDRH, and CBER.


References
  • Drug Development & Approval Process https://www.fda.gov/drugs/development-approval-process-drugs
  • CDRH Learn https://www.fda.gov/training-and-continuing-education/cdrh-learn
  • CBER OTAT Learn: https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otat-learn
Learning Objectives
  • Problem solve and address drug/device regulatory issues as they arise based on activity content.
  • Identify the appropriate FDA office to contact relevant to their medical product submission.
  • Identify and apply several essential components of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submission.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 July 19, 2021
TimeTopicSpeaker
8:40 - 9:00 AM Overview Brenda Stodart, PharmD, BCGP, RAC
9:00 - 9:20 AM Keynote Janet Woodcock, MD
9:20 - 10:20 AM Plenary Peter Marks, MD, PhD
Jeff Shuren, MD, JD
Patrizia Cavazzoni, MD
10:20 - 10:35 AM Break
10:35 - 11:05 AM OND Reorg Updates and OND's COVID-19 Response Kevin Bugin, PhD, RAC
11:05 - 11:15 AM ANDA Efforts Related to COVID-19 John Ibrahim, PharmD, BCPS
11:15 - 11:50 AM Office of Strategic Programs Overview and a Focused Description of Resource Capacity Planning Alison Lyndaker
11:50 - 12:50 PM Lunch
12:50 - 1:25 PM CDER NextGen Portal and Q&A Seyoum Senay, MS
1:25 - 2:00 PM eCTD and Q&A Jonathan Resnick
2:00 - 2:20 PM Break
2:20 - 3:00 PM Product Quality Considerations for Emergency Use Authorizations (EUAs) and Q&A Wendy Wilson, PhD
3:00 - 3:40 PM Strategies to Address Potential Medication Errors for EUA Products for COVID-19 and Q&A Sevan Kolejian, PharmD, MBA, BCPPS
3:40 - 4:20 PM Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends and Q&A QI LIU, PhD
Day 2 July 20, 2021
TimeTopicSpeaker
8:45 - 9:00 AM Day One Overview Forest Ford
9:00 - 10:15 AM CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development and Q&A Kelly Ngan, PharmD, MPH
Andrea Gormley, PharmD, JD
10:15 - 10:55 AM Where Do We Go From Here? How the Ombudsman Can Help and Q&A Virginia Behr, BS
10:55 - 11:15 AM Break
11:15 - 11:45 AM COMMUNICATION Best Practices – Interacting with Regulatory Project Managers in the Office of Regulatory Operations WARE JACQUELINE, PharmD
11:45 - 12:15 PM Office of Communications (OCOMM) - Response to COVID-19 James-Denton Wyllie
12:15 - 1:15 PM Lunch
1:15 - 1:45 PM Office of Regulatory Policy Stefanie Kraus, J.D., MPH
1:45 - 2:25 PM Role of the Product Jurisdiction Team in the Medical Product Development Process Kristina Lauritsen, PhD
2:25 - 2:45 PM Break
2:45 - 3:25 PM Post FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency John Concato, MD
3:25 - 4:05 PM OSI's Role in the Drug Development Process and the Impact of COVID-19 Laurie Muldowney
Day 3 July 21, 2021
TimeTopicSpeaker
8:30 - 8:45 AM CDRH Sessions Overview Elias Mallis
8:45 - 9:25 AM Demystifying Medical Device Regulations Diane Nell, PhD
9:25 - 10:05 AM Accelerating Medical Device Innovation with Regulatory Tools Edward Margerrison
10:05 - 10:25 AM Break
10:25 - 11:05 AM Q-Sub Program: What Is It and Best Practices Susannah Gilbert, MS
11:05 - 11:45 AM The 510(k) Program - Overview and Program Updates Geeta Pamidimukkala
Not offered for CE
11:45 - 12:45 PM Lunch
12:45 - 1:25 PM The 510(k) Program - How to Determine an Effective Predicate Device Melissa Hall
1:25 - 2:05 PM Bioresearch Monitoring Sponsor Inspections Adam Donat
2:05 - 2:25 PM Break
2:25 - 2:35 PM Postmarket Introduction Joseph Tartal
2:35 - 3:15 PM Management Responsibilities at a Glance Vidya Gopal
3:15 - 3:55 PM CAPA at a Glance Tonya Wilbon
3:55 - 4:00 PM CDRH Closing Remarks Joseph Tartal
Day 4 July 22, 2021
TimeTopicSpeaker
8:30 - 8:45 AM CDRH Day Two Overview Joseph Tartal
8:45 - 9:25 AM Medical Device Single Audit Program (MDSAP) Overview Jake Dyer, P.E., PMP
9:25 - 10:05 AM Public MAUDE Database Overview Fariba Maramkhah, Master degree
10:05 - 10:25 AM Break
10:25 - 11:05 AM Additive Manufacturing of Medical Devices Matthew A. Di Prima
11:05 - 11:45 AM FDA Review of Class I and II Recalls Meredith Andress, MPH
11:45 - 11:55 AM Closing of CDRH Sessions Joseph Tartal
11:55 - 12:45 PM Lunch
12:45 - 12:55 PM CBER Sessions Overview Larissa Lapteva, MD
12:55 - 1:25 PM Introduction to the Office of Tissues and Advanced Therapies (OTAT) Wilson Bryan
1:25 - 2:20 PM 21 CFR Part 1271 (known as the "Tissue Rule"): HCT/P Regulatory Framework Scott Brubaker
Safa Karandish, BS, MT
2:20 - 2:30 PM Break
2:30 - 3:10 PM Overview of Product Development for Advanced Therapies under 351 Pathway Jennifer Albert, RN, BSN
3:10 - 3:30 PM Cellular Therapies: Manufacturing Control and Comparability Considerations for Cellular Therapy Products Tom Finn, PhD
3:30 - 3:50 PM Using Consensus Standards in Regulatory Submissions for Biological Products Malcolm Moos, M.D., Ph.D.
3:50 - 4:05 PM Panel Discussion Tom Finn, PhD
Malcolm Moos, M.D., Ph.D.
4:05 - 4:15 PM Break
4:15 - 4:45 PM Preclinical Development Considerations for Cellular Therapies DANIELLE BROOKS, PhD
4:45 - 5:15 PM Development of Cellular Therapies: Clinical Perspective Elizabeth Hart, MD
5:15 - 5:30 PM Panel Discussion DANIELLE BROOKS, PhD
Elizabeth Hart, MD
5:30 - 5:35 PM CBER Closing Remarks Larissa Lapteva, MD
Day 5 July 23, 2021
TimeTopicSpeaker
8:30 - 8:35 AM CBER Day Overview Larissa Lapteva, MD
8:35 - 9:05 AM Expedited Programs for Development of Advanced Therapies Niloofar Kennedy, MS
9:05 - 9:25 AM Practical Applications for Regenerative Medicine Advanced Therapy Designation Tejashri Purohit-Sheth
9:25 - 9:40 AM Panel Discussion Niloofar Kennedy, MS
Tejashri Purohit-Sheth
9:40 - 10:10 AM Development of Gene Therapies from Product Quality Perspective: Genetically Modified Cells Graeme Price, PhD
10:10 - 10:40 AM Chemistry, Manufacturing, and Control Considerations for In Vivo Gene Therapy Products Anna Kwilas, PhD
10:40 - 10:55 AM Panel Discussion Anna Kwilas, PhD
Graeme Price, PhD
10:55 - 11:05 AM Break
11:05 - 11:25 AM Preclinical Development Considerations for Gene Therapies Daniel Urban, PhD
11:25 - 11:50 PM Clinical Development of Gene Therapies: Genetically Modified Cells and Cancer Immunotherapies Asha Das, MD
11:50 - 12:15 PM Clinical Development for In-Vivo Gene Therapy Products Lei Xu, MD, PhD
12:15 - 12:40 PM Panel Discussion Asha Das, MD
Daniel Urban, PhD
Lei Xu, MD, PhD
12:40 - 1:30 PM Lunch
1:30 - 2:10 PM Medical Devices in CBER Andrea Gray
2:10 - 3:00 PM Immunogenicity of Protein Therapeutics Basil Golding
3:00 - 3:50 PM Cell and Gene Therapy Products: Inspectional Experience Ekaterina Allen
3:50 - 3:55 PM CBER & Conference Closing Remarks Larissa Lapteva, MD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 30.25 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 30.25 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-21-064-L04-P for 30.25 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 30.25 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Albert, Jennifer, RN, BSN, Regulatory Project Manager, FDA/CBER/OTAT nothing to disclose
  • Allen, Ekaterina, Lead Consumer Safety Officer (Acting), FDA/CBER/OCBQ/DMPQ/MRB2 nothing to disclose
  • Andress, Meredith, MPH, Recall Coordinator, FDA-ORA nothing to disclose
  • BROOKS, DANIELLE, PhD, Biologist, U.S. Food and Drug Administration nothing to disclose
  • Behr, Virginia, BS, Ombudsman, FDA/CDER/Office of Executive Programs nothing to disclose
  • Brubaker, Scott, Director, FDA/CBER/OTAT/DHT nothing to disclose
  • Bryan, Wilson nothing to disclose
  • Bugin, Kevin, PhD, RAC, Director, Special Programs, US FDA nothing to disclose
  • Cavazzoni, Patrizia, MD, Deputy Director for Operations, Center for Drug Evaluation and Research, Food and Administration, FDA nothing to disclose
  • Concato, John, MD, Supervisory Physician, CDER-OMP nothing to disclose
  • Das, Asha, MD, Physician, OTAT nothing to disclose
  • Di Prima, Matthew A., Materials Scientist, US Food and Drug Administration nothing to disclose
  • Donat, Adam, Deputy Director, Division of Clinical Science and Quality nothing to disclose
  • Dyer, Jake, P.E., PMP, Regulatory Officer, CDRH nothing to disclose
  • Finn, Tom, PhD, CMC reviewer, FDA nothing to disclose
  • Ford, Forest, CSO, FDA nothing to disclose
  • Gilbert, Susannah, MS, Policy Analyst, CDRH nothing to disclose
  • Golding, Basil, supervisory medical officer, HHS, FDA, CBER, OTAT, DPPT nothing to disclose
  • Gopal, Vidya, CSO, FDA/CDRH nothing to disclose
  • Gormley, Andrea, PharmD, JD, Pharmacist, FDA nothing to disclose
  • Gray, Andrea, FDA nothing to disclose
  • Hall, Melissa, Consumer Safety Officer, FDA nothing to disclose
  • Hart, Elizabeth, MD, Branch Chief, General Medicine 1, OTAT, CBER, FDA nothing to disclose
  • Ibrahim, John, PharmD, BCPS, Regulatory Project Manager, FDA nothing to disclose
  • JACQUELINE, WARE, PharmD, Deputy Director, FDA/CDER/OND/ORO nothing to disclose
  • Karandish, Safa, BS, MT, Consumer Safety Officer, Food and Drug Administration nothing to disclose
  • Kennedy, Niloofar, MS, Regulatory Project Manager, OTAT nothing to disclose
  • Kolejian, Sevan, PharmD, MBA, BCPPS, SE/ pharmacist, FDA I received Salary from PRN Pharmacist at Johns Hopkins Hospital for a role as Other - PRN Pharmacist at Johns Hopkins Hospital.
  • Kraus, Stefanie, J.D., MPH, Regulatory Counsel, FDA nothing to disclose
  • Kwilas, Anna, PhD, Lead Biologist, Food and Drug Administration nothing to disclose
  • LIU, QI, PhD, Associate Director for Innovation & Partnership, Office of Clinical Pharmacology | Office of Translational Sciences | Center for Drug Evaluation and I received Stocks from I opened an account on Robinhood on 2/13/2021. The Robinhood app gave me a free share of random stock when I opened the account, and it turned out to be one share of Unity Biotechnology (UBX) with a total worthy of about $8. I tried to sell it immediately but was not able to do so because the App required that I had to hold it for at least 3 trading days before I could sell it. On 2/19, I was notified by the App that the UBX share "has settled and can now be traded". I immediately sold it for $7.79. Now I no longer have any share of UBX. for a role as Other.
  • Lapteva, Larissa, MD, Associate Director, CBER nothing to disclose
  • Lauritsen, Kristina, PhD, Combination Product Policy Advisor, Center for Drug Evaluation and Research nothing to disclose
  • Lyndaker, Alison, Operations Research Analyst, Food and Drug Administration nothing to disclose
  • Mallis, Elias, Director, Division of Industry and Consumer Education, U.S. Food and Drug Administration nothing to disclose
  • Maramkhah, Fariba, Master degree, Consumer Safety Officer, FDA nothing to disclose
  • Margerrison, Edward, Director, Office of Science and Engineering, CDRH nothing to disclose
  • Marks, Peter, MD, PhD, Center Director, FDA/CBER nothing to disclose
  • Moos, Malcolm, M.D., Ph.D., medical officer, FDA nothing to disclose
  • Muldowney, Laurie, Deputy Director, FDA/CDER/OC/OSI nothing to disclose
  • Nell, Diane, PhD, Consumer Safety Officer, CDRH/OCE/DICE nothing to disclose
  • Ngan, Kelly, PharmD, MPH, Chief Project Management Staff, Food and Drug Administration nothing to disclose
  • Pamidimukkala, Geeta, Deputy Division Director, ORP/Div1, FDA nothing to disclose
  • Price, Graeme, PhD, Research Microbiologist, FDA CBER OTAT DCGT nothing to disclose
  • Purohit-Sheth, Tejashri, Director, DCEPT, CBER/OTAT nothing to disclose
  • Resnick, Jonathan, Project Management Officer, FDA, CDER, OBI nothing to disclose
  • Senay, Seyoum, MS, Supervisory Operations Research, FDA nothing to disclose
  • Shuren, Jeff, MD, JD, Director, CDRH, FDA nothing to disclose May reference off-label use.
  • Stodart, Brenda, PharmD, BCGP, RAC, Program Director, FDA nothing to disclose
  • Tartal, Joseph, Division Deputy Director, Division of Industry and Consumer Education My spouse received Other - hourly wage from New Horizons Diagnostics Corporation for a role as Other - contractor, manufacturer. My spouse received Other - hourly wage from New Horizons Diagnostics Corporation for a role as Other - contractor.
  • Urban, Daniel, PhD, Biologist, PTB1 / DCEPT / OTAT / CBER / FDA nothing to disclose
  • Wilbon, Tonya, Branch Chief, FDA/CDRH/OCE/DICE nothing to disclose
  • Wilson, Wendy, PhD, Division Director, CDER/OPQ/ONDP/DNDPII nothing to disclose
  • Woodcock, Janet, MD, Acting Commissioner of Food and Drugs, FDA nothing to disclose
  • Wyllie, James-Denton, Director, Food and Drug Administration nothing to disclose
  • Xu, Lei, MD, PhD, Medical Officer, FDA nothing to disclose

Planning Committee
  • Kleppinger, Cynthia, MD, Medical Officer, FDA nothing to disclose
  • Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI nothing to disclose
  • Stodart, Brenda, PharmD, BCGP, RAC, Program Director, FDA nothing to disclose

CE Consultation and Accreditation Team
  • Catherine Harrison, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 65% of the activity.
ACCME Joint Accreditation
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