US_Flag An official website of the United States government Here's how you know

The .gov means it's official.

Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.


The site is secure.

The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
Regulatory Education for Industry (REdI) Annual Conference
July 19 - 23, 2021

Activity Coordinators:
Lisa Misevicz (,  Carolina Reese (,  Rachel Brown Kichline (,  Larissa Lapteva (,  Elias Mallis (

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.

  • Drug Development & Approval Process
  • CDRH Learn
  • CBER 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.
Day 1 July 19, 2021
Time Topic Speaker
8:40 - 9:00 AM EDT Overview Brenda Stodart, PharmD, MS, BCGP, RAC
9:00 - 9:20 AM EDT Keynote Janet Woodcock, MD
9:20 - 10:20 AM EDT Plenary Peter Marks, MD, PhD
Jeffrey Shuren, MD, JD
Patrizia Cavazzoni, MD
10:20 - 10:35 AM EDT Break
10:35 - 11:05 AM EDT OND Reorg Updates and OND's COVID-19 Response Kevin Bugin, PhD, RAC
11:05 - 11:15 AM EDT ANDA Efforts Related to COVID-19 John Ibrahim, PharmD, BCPS
11:15 - 11:50 AM EDT Office of Strategic Programs Overview and a Focused Description of Resource Capacity Planning Alison Lyndaker
11:50 - 12:50 PM EDT Lunch
12:50 - 1:25 PM EDT CDER NextGen Portal and Q&A Seyoum Senay, MS
1:25 - 2:00 PM EDT eCTD and Q&A Jonathan Resnick, PMP
2:00 - 2:20 PM EDT Break
2:20 - 3:00 PM EDT Product Quality Considerations for Emergency Use Authorizations (EUAs) and Q&A Wendy Wilson, PhD
3:00 - 3:40 PM EDT 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 EDT 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
Time Topic Speaker
8:45 - 9:00 AM EDT Day One Overview Forest Ford, PharmD, R. Ph
9:00 - 10:15 AM EDT 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 EDT Where Do We Go From Here? How the Ombudsman Can Help and Q&A Virginia Behr, BS
10:55 - 11:15 AM EDT Break
11:15 - 11:45 AM EDT COMMUNICATION Best Practices – Interacting with Regulatory Project Managers in the Office of Regulatory Operations WARE JACQUELINE, PharmD
11:45 - 12:15 PM EDT Office of Communications (OCOMM) - Response to COVID-19 James-Denton Wyllie
12:15 - 1:15 PM EDT Lunch
1:15 - 1:45 PM EDT Office of Regulatory Policy Stefanie Kraus, JD, MPH
1:45 - 2:25 PM EDT Role of the Product Jurisdiction Team in the Medical Product Development Process Kristina Lauritsen, PhD
2:25 - 2:45 PM EDT Break
2:45 - 3:25 PM EDT 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 EDT OSI's Role in the Drug Development Process and the Impact of COVID-19 Laurie Muldowney, MD, DO
Day 3 July 21, 2021
Time Topic Speaker
8:30 - 8:45 AM EDT CDRH Sessions Overview Elias Mallis
8:45 - 9:25 AM EDT Demystifying Medical Device Regulations Diane Nell, PhD
9:25 - 10:05 AM EDT Accelerating Medical Device Innovation with Regulatory Tools Edward Margerrison, PhD
10:05 - 10:25 AM EDT Break
10:25 - 11:05 AM EDT Q-Sub Program: What Is It and Best Practices Susannah Gilbert, MS
11:05 - 11:45 AM EDT The 510(k) Program - Overview and Program Updates Geeta Pamidimukkala
Not offered for CE
11:45 - 12:45 PM EDT Lunch
12:45 - 1:25 PM EDT The 510(k) Program - How to Determine an Effective Predicate Device Melissa Hall
1:25 - 2:05 PM EDT Bioresearch Monitoring Sponsor Inspections Adam Donat
2:05 - 2:25 PM EDT Break
2:25 - 2:35 PM EDT Postmarket Introduction Joseph Tartal
2:35 - 3:15 PM EDT Management Responsibilities at a Glance Vidya Gopal
3:15 - 3:55 PM EDT CAPA at a Glance Tonya Wilbon, B.S.
3:55 - 4:00 PM EDT CDRH Closing Remarks Joseph Tartal
Day 4 July 22, 2021
Time Topic Speaker
8:30 - 8:45 AM EDT CDRH Day Two Overview Joseph Tartal
8:45 - 9:25 AM EDT Medical Device Single Audit Program (MDSAP) Overview Jake Dyer, P.E., PMP
9:25 - 10:05 AM EDT Public MAUDE Database Overview Fariba Maramkhah, Master degree
10:05 - 10:25 AM EDT Break
10:25 - 11:05 AM EDT Additive Manufacturing of Medical Devices Matthew A. Di Prima, PhD
11:05 - 11:45 AM EDT FDA Review of Class I and II Recalls Meredith Andress, MPH
11:45 - 11:55 AM EDT Closing of CDRH Sessions Joseph Tartal
11:55 - 12:45 PM EDT Lunch
12:45 - 12:55 PM EDT CBER Sessions Overview Larissa Lapteva, MD
12:55 - 1:25 PM EDT Introduction to the Office of Tissues and Advanced Therapies (OTAT) Wilson Bryan
1:25 - 2:20 PM EDT 21 CFR Part 1271 (known as the "Tissue Rule"): HCT/P Regulatory Framework Scott Brubaker
Safa Karandish, BS, MT
2:20 - 2:30 PM EDT Break
2:30 - 3:10 PM EDT Overview of Product Development for Advanced Therapies under 351 Pathway JENNIFER ALBERT, RN, BSN
3:10 - 3:30 PM EDT Cellular Therapies: Manufacturing Control and Comparability Considerations for Cellular Therapy Products Tom Finn, PhD
3:30 - 3:50 PM EDT Using Consensus Standards in Regulatory Submissions for Biological Products Malcolm Moos, M.D., Ph.D.
3:50 - 4:05 PM EDT Panel Discussion Tom Finn, PhD
Malcolm Moos, M.D., Ph.D.
4:05 - 4:15 PM EDT Break
4:15 - 4:45 PM EDT Preclinical Development Considerations for Cellular Therapies DANIELLE BROOKS, PhD
4:45 - 5:15 PM EDT Development of Cellular Therapies: Clinical Perspective Elizabeth Hart, MD
5:15 - 5:30 PM EDT Panel Discussion DANIELLE BROOKS, PhD
Elizabeth Hart, MD
5:30 - 5:35 PM EDT CBER Closing Remarks Larissa Lapteva, MD
Day 5 July 23, 2021
Time Topic Speaker
8:30 - 8:35 AM EDT CBER Day Overview Larissa Lapteva, MD
8:35 - 9:05 AM EDT Expedited Programs for Development of Advanced Therapies Niloofar Kennedy, MS
9:05 - 9:25 AM EDT Practical Applications for Regenerative Medicine Advanced Therapy Designation Tejashri Purohit-Sheth
9:25 - 9:40 AM EDT Panel Discussion Niloofar Kennedy, MS
Tejashri Purohit-Sheth
9:40 - 10:10 AM EDT Development of Gene Therapies from Product Quality Perspective: Genetically Modified Cells Graeme Price, PhD
10:10 - 10:40 AM EDT Chemistry, Manufacturing, and Control Considerations for In Vivo Gene Therapy Products Anna Kwilas, PhD
10:40 - 10:55 AM EDT Panel Discussion Anna Kwilas, PhD
Graeme Price, PhD
10:55 - 11:05 AM EDT Break
11:05 - 11:25 AM EDT Preclinical Development Considerations for Gene Therapies Daniel Urban, PhD
11:25 - 11:50 PM EDT Clinical Development of Gene Therapies: Genetically Modified Cells and Cancer Immunotherapies Asha Das, MD
11:50 - 12:15 PM EDT Clinical Development for In-Vivo Gene Therapy Products Lei Xu, MD, PhD
12:15 - 12:40 PM EDT Panel Discussion Asha Das, MD
Daniel Urban, PhD
Lei Xu, MD, PhD
12:40 - 1:30 PM EDT Lunch
1:30 - 2:10 PM EDT Medical Devices in CBER Andrea Gray
2:10 - 3:00 PM EDT Immunogenicity of Protein Therapeutics Basil Golding
3:00 - 3:50 PM EDT Cell and Gene Therapy Products: Inspectional Experience Ekaterina Allen
3:50 - 3:55 PM EDT 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.
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.
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-21-064-L04-P for 30.25 contact hour(s).
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 ( 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.

  • 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, Acting Director, FDA/CBER/OTP/OCTHT/DHT - nothing to disclose
  • Bryan, Wilson - nothing to disclose
  • Bugin, Kevin, PhD, RAC, Deputy Super Office Director of Operations, US FDA - nothing to disclose
  • Cavazzoni, Patrizia, MD, Director, Center for Drug Evaluation and Research, 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., PhD, 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, PharmD, R. Ph, 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, Associate Director for Regulatory Affairs, 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, JD, MPH, Senior Regulatory Counsel, FDA - nothing to disclose
  • Kwilas, Anna, PhD, Lead Biologist, Food and Drug Administration - nothing to disclose
  • 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
  • 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.
  • 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, PhD, 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, MD, DO, 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, PMP, Business Informatics Specialist, FDA, CDER, OBI - nothing to disclose
  • Senay, Seyoum, MS, Supervisory Operations Research, FDA - nothing to disclose
  • Shuren, Jeffrey, MD, JD, Director, CDRH, FDA - nothing to disclose May reference off-label use.
  • Stodart, Brenda, PharmD, MS, 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, B.S., 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, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

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