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:: Tue, Aug 16 8:30 AM - 12:30 PM ET
Day2:: Wed, Aug 17 8:30 AM - 12:30 PM ET
Day3:: Thu, Aug 18 8:30 AM - 12:30 PM 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, 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

KEYNOTE SPEAKER

ABOUT THIS CONFERENCE

TOPICS COVERED:

INTENDED AUDIENCE

FDA RESOURCES