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 |
USAID Keynote |
Dr. Atul Gawande |
Tereza Kasaeva, MD, PhD |
|
Rogerio Gaspar, PhD |
|
USP Keynote |
Ronald T. Piervincenzi, PhD |
Jude Nwokike |
|
Deus Mubangizi |
|
Hiiti B. Sillo |
|
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 |
FDA/CBER’s Engagements with the World Health Organization (WHO) |
Gopa Raychaudhuri, PhD |
|
Margaret M. Kober, RPh, MPA |
John Ibrahim, PharmD, BCPS |
|
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 |
|
Ramya Gopinath, MD |
|
FDA’s Use of the Tentative Approval Pathway to Meet the Urgent Needs of PEPFAR |
Tina T. Nhu, PharmD, Mc. PM |
Peter Capella, PhD |
|
Monica Zeballos, PharmD, RPh |
|
Project Facilitate: An Overview of Expanded Access and the Review Process |
Mitchell Chan, PharmD, BCPS |
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 |
|
Frank O. Holcombe, Jr. PhD |
|
Lifecycle Management of Approved Drug Product: FDA Perspective |
Ramesh Raghavachari, PhD |
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 |
|
Mrunal A. Jaywant, PhD, PGDMM |
|
Andre Raw, PhD |
|
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 |
|
Ja Hye Myung, PhD, MS, BPharm |
|
Rong Wang, PharmD, PhD |
|
Essential Elements of Biopharmaceutics Classification System (BCS III)-Based Waiver Request |
Yi Zhang, PhD |
Donna A. Volpe, PhD |
|
Haritha Mandula, PhD |
|
Question & Answer Panel |
Ja Hye Myung, Rong Wang, Yi Zhang, Donna A. Volpe, and Haritha Mandula |
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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