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Agenda

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ABOUT THIS EVENT

This workshop will focus on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post pandemic world. Presentations and panel discussions will provide information on the recent updates made to ICH E6(r3) and regulatory perspectives on implementation of proportionate and risk-based approaches to the design and conduct of the trial to help ensure that the quality of the trial data generated is of sufficient quality to support good decision making. Panelists will discuss continuing developments in novel operational approaches, data sources, and technologies used in clinicals trials, as well as novel approaches to regulatory inspections.

The event will also include sessions dedicated to the conduct of bioequivalence (BE) studies. Regulators will provide their perspectives on common issues and challenges in the conduct of the clinical and bioanalytical components of BE studies and provide important updates on guidance and inspection activities.

Regulators will also discuss insights into key pharmacovigilance (PV) compliance topics, and the audience will have the opportunity to hear first-hand from regulators about regulatory updates and ongoing collaborative efforts among the international regulatory agencies by conducting and observing inspections, sharing inspection information, and developing policy.

INTENDED AUDIENCE

• Researchers and Clinical trial sponsors considering the use of decentralized trial design or Real-World Data
• Organisations sponsoring, conducting, managing or submitting bioequivalence/bioavailability clinical trials for licensing purposes such as the Abbreviated New Drug Application (ANDA) and Biologic License Application (BLA)
• Regulatory Affairs and Clinical Research Quality Management Professionals
• Specialist providers of digital health technologies
• Consultants focused on provision of GCP training, inspection support or quality management
• Foreign and national regulators
• Academic
• Government or private institutions
• Pharmaceutical and biotechnology companies
• Contract Research Organizations/Site Management Organizations
• All those who are involved in the management of clinical trials, including investigators, research coordinators, monitors and consultants.

TOPICS COVERED

• Key updates to ICH E6(R3)
• The use of technology in clinical trials
• Updates for trials incorporating decentralized clinical trials (DCT) features
• ICH E6R3 data governance updates
• Risk-based approach to sponsor oversight
• Changes in clinical trial activities, inspections, and remote regulatory assessments/ remote inspections
• Policy/guidance updates
• Clinical and bioanalytical challenges in bioequivalence studies
• Updates in guidance, polices, and initiatives by each agency

FDA RESOURCES

• Decentralized Clinical Trials for Drugs, Biological Products, and Devices
• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Q&A (FDA
• M10 Bioanalytical Method Validation and Study Sample Analysis (FDA)
• Postmarketing Adverse Event Reporting Compliance Program (FDA- PhV)
• Good Clinical Practice Resources from Health Canada

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.
• 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.
• 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.
• 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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