Symposium | Virtual

Event Title

A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium

February 13 - 15, 2024

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

Topics & Presentations Day 1	Speakers
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One – AM
Day One Opening Remarks & Keynote Recording	Patrizia Cavazzoni, MD Director Center for Drug Evaluation & Research (CDER) \| FDA
Session 1: Good Clinical Practice (GCP) Harmonization: Updates to ICH E6(R3) Recording and Slides	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) Recording and Slides	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 Recording and Slides	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 Recording and Slides	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
Discussion Panel: Sessions 1-4 Recording	Moderator: Regina Zopf, MD Senior Medical Officer Good Clinical Practice Assessment Branch (GCPAB) DCCE \| OSI \| OC \| CDER \| FDA Panelists: Leigh Marcus, Hocine Abid, Andrew Fisher, Debbi Fox, Elena Boley, Mandy Budwal-Jagait, Lee Pai-Scherf, Cheryl Grandinetti, Shila Rastegar And Jason Wakelin-Smith, BSc Expert GCP Inspector and Head of the Compliance Expert Circle MHRA
Day One Wrap-Up & Closing Remarks Recording and Slides	Hocine Abid

Topics & Presentations Day 2	Speakers
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – AM
Day Two Opening Remarks & Keynote Recording and Slides	James Pound, BSc, CChem Deputy Director Standards and Compliance MHRA
Session 1: Sponsor Oversight in Clinical Trials Recording and Slides	Session Moderator: Adil Nashed, BVSc, DHMS Regulatory Compliance and Enforcement Specialist HC Presenters: 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, BSc Expert GCP Inspector and Head of the Compliance Expert Circle MHRA
Session 2: Clinical Trials Post Pandemic – Positive Disruption to Establish Ways of Working? Recording and Slides	Session Moderator: 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 Presenters: Jason Wakelin-Smith And 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
Session 3: The Future of GCP Inspections Recording and Slides	Session Moderator: Kassa Ayalew, MD, MPH Division Director Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) Office of Compliance (OC) CDER \| FDA Presenters: 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
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – PM
Session 4: Agency Updates: Policies, Guidances, and Initiatives Recording	Session Moderator: Emily Gebbia, JD Associate Director of Regulatory Development OSI \| OC \| CDER \| FDA Presenters: Hocine Abid And Stephen Vinter, BSc, CChem Head of Compliance Team 1 MHRA
Session 5: Collaboration Between Agencies and Future Expectations Recording and Slides	Session Moderator: Mandy Budwal-Jagait, MSc Head of GCP and Lead Senior GCP Inspector MHRA Presenters: LaKisha Williams, MSN Commander (CDR) \| USPHS GCP International Liaison DCCE \| OSI \| OC \| CDER \| FDA Reza Salehzadeh-Asl, MSc National Supervisor ROEB \| HC
Discussion Panel: Sessions 1-5 Recording	Moderator: Ryan Raffaelli, MD Lead Physician DCCE \| OSI \| OC \| CDER \| FDA Panelists: Adil Nashed, Barbara Wright, Jennifer Evans, Richard Berning, Jenn Sellers, Jennifer Adams, Mandy Budwal-Jagait, Emily Gebbia, Stephen Vinter, Hocine Abid, LaKisha Williams, Reza Salehzadeh-Asl And Jason Wakelin-Smith Expert GCP Inspector and Head of the Compliance Expert Circle MHRA
Day Two Wrap-Up & Closing Remarks Recording	Cheryl Grandinetti

Topics & Presentations Day 3	Speakers
Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Three – AM
Day Three Opening Remarks & Keynote Recording	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 Recording and Slides	Session Moderator: Sean Kassim, PhD Director Office of Study I OSIS \| OTS \| CDER \| FDA Presenters: 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 Recording and Slides	Session Moderator: Sean Kassim Presenters: Michael McGuinness And Yiyue Cynthia Zhang, PhD, RAC Senior Staff Fellow Division of New drug Study Integrity (DNDSI) OSIS \| OTS \| CDER \| FDA
Q&A Discussion Panel Recording	Moderator: Sean Kassim Panelists: Mei Ou, Michael McGuinness, and Yiyue Cynthia Zhang
Session 3 (BE): Clinical Study Conduct Recording and Slides	Session Moderator: Jason Wakelin-Smith Expert GCP Inspector and Head of the Compliance Expert Circle MHRA Presenters: Doug Pham, JD, PharmD Associate Director OSIS \| OTS \| CDER \| FDA Emma Whale, MSc Senior GCP & GLP Inspector MHRA
Q&A Discussion Panel Recording	Moderator: Jason Wakelin-Smith Panelists: Michael McGuinness, 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 Recording and Slides	Stephen Vinter, BSc, CChem Head of Compliance \| Team 1 Healthcare Quality and Access MHRA
Session 4 (PV): International Collaboration Recording and Slides	Session Moderator: 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 Presenters: 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 Recording and Slides	Session Moderator: Carolyn Volpe Presenters: 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 Recording and Slides	Session Moderator: Carolyn Volpe Panelists: 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
Discussion Panel: Session4-6 Recording	Moderator: Carolyn Volpe Panelists: Claire Longman, Paul Baillargeon, Peter Diak, Ginneh Stowe, Chrissy Cochran, Lauren Bateman, and Suranjan De
Symposium Wrap-Up & Closing Remarks Recording	Laurie Muldowney, MD Deputy Director OSI \| OC \| CDER \| FDA

Agenda

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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

Topics & Presentations Day 1

Speakers

Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One – AM

Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One – PM

Topics & Presentations Day 2

Speakers

Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – AM

Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – PM

Topics & Presentations Day 3

Speakers

Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Three – AM

Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Three – PM

INTENDED AUDIENCE

TOPICS COVERED

FDA RESOURCES