A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium February 13 - 15, 2024

Symposium | Virtual

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• Date: February 13 - 15, 2024
• Day1: Tue, Feb 13 8:30 a.m. - 03:35 p.m. ET
• Day2: Wed, Feb 14 8:30 a.m. - 03:50 p.m. ET
• Day3: Thu, Feb 15 8:30 a.m. - 04:50 p.m. ET

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Topics & Presentations Day 1	Speakers
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One – AM
Day One Opening Remarks & Keynote	Patrizia Cavazzoni, MD Director Center for Drug Evaluation & Research (CDER) | FDA
Session 1: Good Clinical Practice (GCP) Harmonization: Updates to ICH E6(R3)	Kassa Ayalew, MD, MPH Division Director Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) Office of Compliance (OC) CDER | FDA Leigh Marcus, MD Senior Physician DCCE | OSI | OC | CDER | FDA Hocine Abid, MD, MBA National Manager Regulatory Operations and Enforcement Branch (ROEB) Health Canada (HC) Andrew Fisher, BSc Lead Senior Good Clinical Practice (GCP) Inspector Medicines and Healthcare products Regulatory Agency (MHRA)
Session 2: Technology in Clinical Trials – Digital Health Technology (DHT)	Debbi Fox, BSc Compliance Specialist ROEB | HC Elena Boley, MD, MBA Senior Physician DCCE | OSI | OC | CDER | FDA Mandy Budwal-Jagait, MSc Head of GCP and Lead Senior GCP Inspector MHRA
Session 3: Clinical Trials with Decentralized Elements and GCP Inspections	Karen Bleich, MD Lead Physician Division of Clinical Trial Quality (DCTQ) Office of Medical Policy Initiatives (OMPI) Office of Medical Policy (OPM) CDER | FDA Lee Pai-Scherf, MD Senior Medical Officer Good Clinical Practice Assessment Branch (GCPAB) DCCE | OSI | OC | CDER | FDA Alicja Kasina, MSc Senior Regulatory Advisor ROEB | HC Hayley Dixey, BSc Lead Senior GCP Inspector MHRA
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One – PM
Session 4 - ICH E6 (R3) Draft – Good Data Governance Practices	Cheryl Grandinetti, PharmD Clinical Pharmacologist DCCE | OSI | OC | CDER | FDA Shila Rastegar, MSc Regulatory Compliance and Enforcement Specialist Clinical Trial Compliance Program (CTCP) ROEB | HC Andrew Fisher, BSc Lead Senior GCP Inspector MHRA
Session 1 Discussion Panel	Regina Zopf, MD Senior Medical Officer Good Clinical Practice Assessment Branch (GCPAB) DCCE | OSI | OC | CDER | FDA And Leigh Marcus, Hocine Abid, Andrew Fisher
Session 2 Discussion Panel	Regina Zopf, Debbi Fox, Elena Boley, and Mandy Budwal-Jagait
Session 3 Discussion Panel	Regina Zopf, Lee Pai-Scherf, Hocine Abid, And Jason Wakelin-Smith, BSc Expert GCP Inspector and Head of the Compliance Expert Circle MHRA
Session 4 Discussion Panel	Regina Zopf, Cheryl Grandinetti, Shila Rastegar, and Andrew Fisher
Day One Wrap-Up & Closing Remarks	Hocine Abid

 

Topics & Presentations Day 2	Speakers
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – AM
Day Two Opening Remarks & Keynote	James Pound, BSc, CChem Deputy Director Standards and Compliance MHRA
Session 1: Sponsor Oversight in Clinical Trials	Adil Nashed, BVSc, DHMS Regulatory Compliance and Enforcement Specialist HC Barbara Wright, BA Foreign Cadre Director Foreign BIMO Cadre Office of Bioresearch Monitoring Operations (OBIMO) Office of Medical Products and Tobacco Operations (OMPTO) Office of Regulatory Affairs (ORA) | FDA And Jason Wakelin-Smith
Session 2: Clinical Trials Post Pandemic – Positive Disruption to Establish Ways of Working?	Iram Hassan, PhD Lieutenant Commander (LCDR) | United States Public Health Service (USPHS) Reviewer Good Clinical Practice Compliance Oversight Branch (GCPCOB) DCCE | OSI | OC | CDER | FDA Jennifer Evans, BSc Regulatory Compliance and Enforcement Specialist HC Richard Berning Foreign Cadre Inspector Office of Bioresearch Monitoring (OBIMO) Office of Regulatory Affairs (ORA) | FDA And Jason Wakelin-Smith
Session 3: The Future of GCP Inspections	Jenn Sellers, MD, PhD Branch Chief Good Clinical Practice Assessment Branch (GCPAB) DCCE | OSI | OC | CDER | FDA Jennifer Adams, MPH LCDR | USPHS Foreign Cadre Director OBIMO | ORA | FDA Rachel Mead, BSc Senior GCP Inspector MHRA And Kassa Ayalew
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – PM
Session 4: Agency Updates: Policies, Guidances, and Initiatives	Emily Gebbia, JD Associate Director of Regulatory Development OSI | OC | CDER | FDA Stephen Vinter, BSc, CChem Head of Compliance Team 1 MHRA And Hocine Abid
Session 5: Collaboration Between Agencies and Future Expectations	LaKisha Williams, MSN Commander (CDR) | USPHS GCP International Liaison DCCE | OSI | OC | CDER | FDA Reza Salehzadeh-Asl, MSc National Supervisor ROEB | HC And Mandy Budwal-Jagait
Session 1 Discussion Panel	Adil Nashed, Barbara Wright, and Jason Wakelin-Smith
Session 2 Discussion Panel	Jennifer Evans, Richard Berning, and Jason Wakelin-Smith
Session 3 Discussion Panel	Jenn Sellers, Jennifer Adams, and Mandy Budwal-Jagait
Session 4 Discussion Panel	Emily Gebbia, Stephen Vinter, and Hocine Abid
Session 5 Discussion Panel	LaKisha Williams, Reza Salehzadeh-Asl, and Mandy Budwal-Jagait
Day Two Wrap-Up & Closing Remarks	Cheryl Grandinetti

 

Topics & Presentations Day 3	Speakers
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Three – AM
Presentations:
Day Three Opening Remarks & Keynote	Seongeun (Julia) Cho, MD Division Director Division of Generic Drug Study Integrity (DGDSI) Office of Study Integrity and Surveillance (OSIS) Office of Translational Sciences (OTS) Center for Drug Evaluation and Research (CDER) | FDA
Session 1 (BE): Remote Evaluations	Sean Kassim, PhD Director Office of Study I OSIS | OTS | CDER | FDA Mei Ou, PhD Lead Pharmacokineticist DGDSI | OSIS | OTS | CDER | FDA Michael McGuinness Head of GLP & Laboratories | Head UK GLPMA MHRA
Session 2 (BE): Bioanalytical Issues	Sean Kassim, Michael McGuinness, And Yiyue Cynthia Zhang, PhD, RAC Senior Staff Fellow Division of New drug Study Integrity (DNDSI) OSIS | OTS | CDER | FDA
Session 1 Discussion Panel	Sean Kassim, Mei Ou, and Michael McGuinness
Session 2 Discussion Panel	Sean Kassim, Mei Ou, and Michael McGuinness
Session 3 (BE): Clinical Study Conduct	Jason Wakelin-Smith And Doug Pham, JD, PharmD Associate Director OSIS | OTS | CDER | FDA Emma Whale, MSc Senior GCP & GLP Inspector MHRA
Session 3 Discussion Panel	Jason Wakelin-Smith, Doug Pham, And Jennifer Adams, MPH Lieutenant Commander (LCDR) United States Public Health Service (USPHS) Foreign Cadre Director Office of Bioresearch Monitoring Operations (OBIMO) Office of Regulatory Affairs (ORA) | FDA
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Three – PM
Pharmacovigilance Compliance Keynote	Stephen Vinter, BSc, CChem Head of Compliance | Team 1 Healthcare Quality and Access MHRA
Session 4 (PV): International Collaboration	Carolyn Volpe, PharmD, MS Regulatory Officer Division of Enforcement and Postmarketing Safety (DEPS) Office of Scientific Investigations (OSI) Office of Compliance (OC) Center for Drug Evaluation and Research (CDER) | FDA Claire Longman, MSc Expert Pharmacovigilance Inspector MHRA Sherry Bous, PharmD Division Director DEPS | OSI | OC | CDER | FDA Paul Baillargeon Regulatory Compliance and Enforcement Specialist HC
Session 5 (PV): Future of Inspections	Carolyn Volpe And Ginneh Stowe, MS Health Scientist Oncology Center of Excellence (OCE) | FDA Peter Diak, PharmD, MPH Captain (CAPT) | United States Public Health Service (USPHS) Branch Chief Postmarketing Safety Branch (PSB) DEPS | OSI | OC | CDER | FDA Chrissy Cochran, PhD Director Office of Bioresearch Monitoring Operations (OBIMO) Office of Medical Products and Tobacco Operations (OMPTO) Office of Regulatory Affairs (ORA) | FDA Robert Ball, MD, MPH, ScM Deputy Director Office of Surveillance and Epidemiology (OSE) CDER | FDA
Session 6 (PV): Regulatory Updates	Carolyn Volpe And Claire Longman, MSc Expert Pharmacovigilance Inspector MHRA Lauren Bateman, MS Senior Informatics Advisor Office of Clinical Policy and Programs (OCPP) Office of the Commissioner (OC) | FDA Suranjan De, MS, MBA Deputy Director of the Regulatory Science Staff OSE | CDER | FDA
Session 4 Discussion Panel	Carolyn Volpe, Claire Longman, Paul Baillargeon, and Peter Diak
Session 5 Discussion Panel	Carolyn Volpe, Ginneh Stowe, Peter Diak, and Chrissy Cochran
Session 6 Discussion Panel	Carolyn Volpe, Lauren Bateman, Suranjan De, and Claire Longman
Symposium Wrap-Up & Closing Remarks	Laurie Muldowney, MD Deputy Director OSI | OC | CDER | FDA

 

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