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  4. Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines - 08/16/2022
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Virtual | Virtual

Event Title
Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines
August 16 - 18, 2022


Date:
August 16 - 18, 2022
Day1:
- ET
Day2:
- ET
Day3:
- ET

 

Topics & Presentations Day 1

Speakers

Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 1-Session 1

 

FDA Keynote

Janet Woodcock, MD
Principal Deputy Commissioner
Office of The Commissioner
U.S. Food and Drug Administration (FDA)

USAID Keynote

Dr. Atul Gawande
Assistant Administrator for Global Health
United States Agency for International Development (USAID)

WHO Keynote

Tereza Kasaeva, MD, PhD
Director
Global TB Programme
World Health Organization (WHO)

Effective and Efficient Regulatory Systems

Rogerio Gaspar, PhD
Director of Regulation and Prequalification
WHO

USP Keynote

Ronald T. Piervincenzi, PhD
Chief Executive Officer
United States Pharmacopeia (USP)

Promoting the Quality of Medicines Plus (PQM+) Program

Jude Nwokike
Vice President & Director
Promoting the Quality of Medicines Plus (PQM+) Program
U.S. Pharmacopeial Convention

WHO Prequalification Process for Medicines: Collaborative Registration Procedure for WHO Prequalified Medicines

Deus Mubangizi
Unit Head, Prequalification Unit (PQT)
Regulation and Prequalification Department (RPQ)
Access to Medicines and Health Products Division (MHP)
World Health Organization (WHO)

Collaborative Registration Procedure for WHO Prequalified Medicines and Its Impact on Accelerated Registration and Timely Access to Quality-assured Medicines in LMICs

Hiiti B. Sillo
Unit Head, Regulation and Safety
RPQ | MHP | WHO 

Questions & Answer Panel

Deus Mubangizi and Hiiti B. Sillo

Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 1-Session 2 

 

Opportunities for International Engagement: Regulatory Cooperation, Convergence and Harmonization

C. Michelle Limoli, PharmD
Senior International Health Science Advisor 
CBER International Affairs
Office of the Director (OD)
Center for Biologics Evaluation and Research (CBER) FDA 

FDA/CBER’s Engagements with the World Health Organization (WHO)

Gopa Raychaudhuri, PhD
Associate Director for Special Programs
Office of the Director | CBER | FDA

The New Drug Approval Process

 

Margaret M. Kober, RPh, MPA
Chief, Project Management Staff
Office of Regulatory Operations (ORO)
Office of New Drugs (OND) | CDER

ANDA Approval Process

John Ibrahim, PharmD, BCPS
Associate Director for Regulatory Affairs
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD) | CDER

Questions & Answer Panel

C. Michelle Limoli, Gopa Raychaudhuri, Margaret M. Kober, and John Ibrahim

 

Topics & Presentations Day 2

Speakers

Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 2-Session 1

 

Bringing New TB Drugs to Market: A Regulatory Perspective

Ramya Gopinath, MD
Medical Officer
Division of Anti-Infectives (DAI)
OND | CDER

FDA’s Use of the Tentative Approval Pathway to Meet the Urgent Needs of PEPFAR

Tina T. Nhu, PharmD, Mc. PM
Commander (CDR), USPHS
Team Leader, Regulatory Project Manager
Division of Project Management (DPM)
Office of Generic Drugs (OGD) | CDER 

Drug Product Quality Assessment Considerations Under PEPFAR

Peter Capella, PhD
Director
Division of Immediate and Modified Release Products II (DIMRPII)
Office of Lifecycle Drug Products (OLDP)
Office of Pharmaceutical Quality (OPQ) | CDER 

Nineteen Years of PEPFAR

Monica Zeballos, PharmD, RPh
Captain (CAPT), USPHS
Senior Program Consultant
Division of Antivirals (DAV)
Office of Infectious Diseases (OID) OND | CDER

Project Facilitate: An Overview of Expanded Access and the Review Process

Mitchell Chan, PharmD, BCPS
Lieutenant Commander, USPHS
Clinical Analyst
Team Leader
, Project Facilitate
Oncology Center of Excellence (OCE) | FDA 

Questions & Answer Panel

Ramya Gopinath, Tina T. Nhu, Peter Capella, Monica Zeballos, and Mitchell Chan

Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 2-Session 2

 

Stability – Why Do We Care? / Justifying Your Product!

Frank O. Holcombe, Jr. PhD
Senior Advisor, Immediate Office (IO) 
OLDP | OPQ | CDER | FDA

Lifecycle Management of Approved Drug Product: FDA Perspective

Ramesh Raghavachari, PhD
Chief, Branch I
Division of Post Marketing Activities I (DPMAI)
OLDP | OPQ | CDER

Question & Answer Panel

Frank O. Holcombe and Ramesh Raghavachari

 

Topics & Presentations Day 3

Speakers

Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 3-Session 1

 

Identification and Control of Harmful Impurities in Pharmaceutical Products: Nitrosamine as an Example

Mrunal A. Jaywant, PhD, PGDMM
Senior Director, R&D
USP Nitrosamines Lead
Unites States Pharmacopoeia (USP) India

Control of Nitrosamine Impurities in Human Drugs

Andre Raw, PhD
Associate Director for Science and Communication
Office of Lifecycle Drug Products (OLDP)
Office of Pharmaceutical Quality (OPQ) | CDER

Question & Answer Panel

Mrunal A. Jaywant and Andre Raw

Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 3-Session 2

 

Introduction to Bioequivalence for Generic Drug Products

Ja Hye Myung, PhD, MS, BPharm
Pharmacologist
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD) | CDER | FDA

Bioequivalence Studies for Generic Drug Development

Rong Wang, PharmD, PhD
Acting Division Associate Director
Division of Bioequivalence I (DBI)
OB | OGD | CDER | FDA

Essential Elements of Biopharmaceutics Classification System (BCS III)-Based Waiver Request

Yi Zhang, PhD
Commander, USPHS
Senior Advisor
Division of Therapeutic Performance II (DTPII)
Office of Research and Standards (ORS)
OGD | CDER | FDA

BCS Methodology: Solubility, Permeability & Dissolution

Donna A. Volpe, PhD
Research Chemist
Division of Applied Regulatory Science
Office of Clinical Pharmacology (OCP)
CDER | FDA

Biowaiver Aspects from a Biopharmaceutics Perspective: Our role in A/NDA original and post-approval Applications

Haritha Mandula, PhD
Senior Pharmaceutical Quality Assessor
Division of Biopharmaceutics
OND | CDER | FDA

Question & Answer Panel

Ja Hye Myung, Rong Wang, Yi Zhang, Donna A. Volpe, and Haritha Mandula

 

AGENDA

Visit CDER Small Business and Industry Assistance Page

KEYNOTE SPEAKER

Janet Woodcock, MD


Janet Woodcock, M.D.
Principal Deputy Commissioner - Office Of The Commissioner
U.S. Food and Drug Administration (FDA)

ABOUT THIS CONFERENCE

CDER SBIA is hosting this three half-days conference in collaboration with the Promoting the Quality of Medicines Plus (PQM+) program, which is funded by the U.S. Agency for International Development (USAID) and led by the United States Pharmacopeial Convention. PQM+ provides technical assistance to build in-country capacity of medical products regulatory authorities’ QA systems in low-and middle-income countries (LMICs). PQM+ also provides technical support to manufacturers of quality-assured priority medical products for tuberculosis (TB), malaria, neglected tropical diseases, other infectious diseases, and family planning and reproductive health as well as maternal, newborn, and child health.

This event is intended to help National Medicines Regulatory Authority's (NMRA) in low-and middle-income countries (LMICs) gain a better understanding of the following:

  • FDA's role in international regulatory harmonization.
  • How FDA interacts with the World Health Organization (WHO) and NMRAs to support the process for approving drugs in LMICs.
  • USP and USAID’s PQM+ program’s role in supporting of strengthening regulatory systems in LMICs.
  • Regulatory resources available to NMRAs in LMICs.

TOPICS COVERED:

  • International Regulatory Harmonization
  • FDA International Collaborations, including WHO
  • FDA drug approval pathways and FDA review of drug applications (new and generic drugs). Specific emphasis will be made on approval pathways for new TB medicines.
  • FDA review of stability testing, bioequivalence and post-marketing changes
  • Nitrosamines Impurities
  • USP and USAID’s PQM+ capabilities for strengthening regulatory systems in LMIC.

INTENDED AUDIENCE

  • Global regulators, particularly those from low- and middle-income countries (LMICs)
  • Regulatory science and regulatory affairs professionals, industry, consultants, or contractors who are involved with:
    • The submission of INDs, NDAs, BLAs and ANDAs
    • New and generic drug development
    • Generic drug bioequivalence, stability, biowaivers and dissolution
  • Global public health programs supporting access to quality-assured medicines

FDA RESOURCES

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