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Speakers

# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

Hocine Abid, MD, MBA | Health Canada

National manager

Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

Kamaldeep Ajimal, MPharm | MHRA

GCP inspector

Medicines and Healthcare products Regulatory Agency (MHRA)

Scott Appleton, PhD, M.Sc. | Health Canada

Manager

Bureau of Pharmaceutical Sciences (BPS), Pharmaceutical Drugs Directorate (PDD), Health Products and Food Branch (HPFB), Health Canada (HC)

Kassa Ayalew, MD, MPH | FDA

Division Director

Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

B

Alex Basiji, M.Sc. | Health Canada

National Director

Clinical and Border Compliance Programs (CBCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

Nahid Bibak, B.Sc. | Health Canada

Compliance and Enforcement Specialist

Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

Elena Boley, MD, MBA | FDA

Senior Medical Reviewer

Good Clinical Practice Assessment Branch (GCPAB), Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Sherry Bous, PharmD | FDA

Director

Division of Enforcement and Postmarketing Safety (DEPS), Office of Scientific Investigations (OSI), Food and Drug Administration (FDA)

Mandy Budwal-Jagait, M.Sc. | MHRA

Deputy Director

Standards and Compliance, Medicines and Healthcare products Regulatory Agency (MHRA)

David Burrow, PharmD, JD | FDA

Director

Office of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

C

Seonguen Julia Cho, PhD | FDA

Division Director

Division of Generic Drug Study Integrity (DGDSI), Office of Study Integrity and Surveillance (OSIS), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

D

Arindam Dasgupta, PhD | FDA

Acting Division Director

Division of New Drug Study Integrity (DNDSI), Office of Study Integrity and Surveillance (OSIS), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Anastasia Daskajiannis St John, B.Sc. | MHRA

GPvP inspector

Medicines and Healthcare products Regulatory Agency (MHRA)

E

Anna Edmison, PhD | Health Canada

Senior Clinical Assessment Officer

Bureau of Pharmaceutical Sciences (BPS), Pharmaceutical Drugs Directorate (PDD), Health Products and Food Branch (HPFB), Health Canada (HC)

Jennifer Evans, B.Sc. | Health Canada

Compliance and Enforcement Specialist

Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

F

Andrew Fisher, B.Sc. (Hons) | MHRA

Lead Senior GCP Inspector

Medicines and Healthcare products Regulatory Agency (MHRA)

Debbi Fox, B.Sc. | Health Canada

Compliance and Enforcement Specialist

Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

G

Michelle Gabriel, B.Sc. (Hons), M.Sc. | MHRA

Head of GCP & GCP Inspector

Medicines and Healthcare products Regulatory Agency (MHRA)

Kim Godard, PhD | Health Canada

Director General

Health Product Compliance Directorate (HPCD), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

Cheryl Grandinetti, PharmD |FDA

Associate director for clinical policy

Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

H

Iram Hassam, PhD | FDA

Reviewer

USPHS Scientist Officer, Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Ricardo J. Hernández, PharmD, MPH | FDA

Pharmacist

Drug Safety Operations (DSO), Office of the Center Director (OCD), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

I

Andrea Ibrahim, M.Sc.| Health Canada

Senior Clinical Evaluator

Office of Clinical Trials (OCT), Pharmaceutical Drugs Directorate (PDD), Health Products and Food Branch (HPFB), Health Canada (HC)

K

Dipti Kalra, RPh, MS, MBA | FDA

Branch Chief

Postmarketing Safety Branch (PSB), Office of Compliance, Food and Drug Administration (FDA)

Sean Kassim, PhD | FDA

Office Director

Office of Study Integrity and Surveillance (OSIS), Office of Translational Sciences (OTS), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Lydia Kim, MD | FDA

Medical reviewer

Good Clinical Practice Assessment Branch (GCPAB), Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Namita Kothary, PharmD, RAC (US) | FDA

Associate Director for Scientific Affairs

Division of Enforcement and Postmarketing Safety (DEPS), Office of Scientific Investigations (OSI), Food and Drug Administration (FDA)

L

Claire Longman, M.Sc. | MHRA

Expert Pharmacovigilance Inspector

Medicines and Healthcare products Regulatory Agency (MHRA)

M

Leigh Marcus, MD | FDA

Senior Medical Reviewer

Good Clinical Practice Assessment Branch (GCPAB), Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Michael McGuinness | MHRA

Head of GLP & Laboratories, Head UK GLPMA

Healthcare Quality and Access – Standards & Compliance, Medicines and Healthcare products Regulatory Agency (MHRA)

Rachel Mead, B.Sc. (Hons) | MHRA

Senior GCP Inspector

Medicines and Healthcare products Regulatory Agency (MHRA)

Laurie Muldowney, MD | FDA

Deputy Director

Office of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

R

Sophie Radicke, M.Sc. | MHRA

Head of GPvP and Senior Pharmacovigilance Inspector

Medicines and Healthcare products Regulatory Agency (MHRA)

Ryan Raffaelli, MD | FDA

Team Lead

GCP Compliance Oversight Branch (GCPCOB), Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Shila Rastegar, M.Sc. | Health Canada

Compliance and Enforcement Specialist

Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

S

Reza Salehzadeh-Asl, M.Sc. | Health Canada

National supervisor

Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

Myriam Salem, M.Sc. | Health Canada

National Supervisor

Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)

Jenn W. Sellers, MD, PhD | FDA

Branch chief

GCPAB Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Susan Stojdl, M.Sc. | Health Canada

Senior Clinical Assessment Officer

Bureau of Pharmaceutical Sciences (BPS), Pharmaceutical Drugs Directorate (PDD), Health Products and Food Branch (HPFB), Health Canada (HC)

V

Stephen Vinter, B.Sc. (Hons), CChem FRSC | MHRA

Head of Compliance

Standards and Compliance Team 1, Medicines and Healthcare products Regulatory Agency (MHRA)

W

Jason Wakelin-Smith, B.Sc. (Hons), PGDip | MHRA

Expert GCP Inspector and Head of the Compliance Expert Circle

Medicines and Healthcare products Regulatory Agency (MHRA)

Emma Whale, M.Sc. | MHRA

Senior GCP & GLP Inspector

Medicines and Healthcare products Regulatory Agency (MHRA)

LaKisha Williams, DHA, MSN, PMHNP-BC, CRNP | FDA

Commander (CDR), USPHS GCP International Liaison

Office of Scientific Investigations (OSI), Division of Clinical Compliance Evaluation (DCCE), Office of Compliance (OC), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)

Z

Regina Zopf, MD, MPH | FDA

Senior Medical Officer

Good Clinical Practice Assessment Branch (GCPAB), Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)