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AGENDA

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KEYNOTE SPEAKER

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

• United States Pharmacopeia (USP)
• Promoting Quality of Medicines Plus (PQM+)

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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