Speakers
A
National manager
Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
GCP inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
Manager
Bureau of Pharmaceutical Sciences (BPS), Pharmaceutical Drugs Directorate (PDD), Health Products and Food Branch (HPFB), Health Canada (HC)
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
National Director
Clinical and Border Compliance Programs (CBCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
Compliance and Enforcement Specialist
Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
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)
Director
Division of Enforcement and Postmarketing Safety (DEPS), Office of Scientific Investigations (OSI), Food and Drug Administration (FDA)
Deputy Director
Standards and Compliance, Medicines and Healthcare products Regulatory Agency (MHRA)
Director
Office of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
C
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
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)
GPvP inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
E
Senior Clinical Assessment Officer
Bureau of Pharmaceutical Sciences (BPS), Pharmaceutical Drugs Directorate (PDD), Health Products and Food Branch (HPFB), Health Canada (HC)
Compliance and Enforcement Specialist
Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
F
Lead Senior GCP Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
Compliance and Enforcement Specialist
Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
G
Head of GCP & GCP Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
Director General
Health Product Compliance Directorate (HPCD), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
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
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)
Pharmacist
Drug Safety Operations (DSO), Office of the Center Director (OCD), Center for Drug Evaluation & Research (CDER), Food and Drug Administration (FDA)
I
Senior Clinical Evaluator
Office of Clinical Trials (OCT), Pharmaceutical Drugs Directorate (PDD), Health Products and Food Branch (HPFB), Health Canada (HC)
K
Branch Chief
Postmarketing Safety Branch (PSB), Office of Compliance, Food and Drug Administration (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)
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)
Associate Director for Scientific Affairs
Division of Enforcement and Postmarketing Safety (DEPS), Office of Scientific Investigations (OSI), Food and Drug Administration (FDA)
L
Expert Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
M
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)
Head of GLP & Laboratories, Head UK GLPMA
Healthcare Quality and Access – Standards & Compliance, Medicines and Healthcare products Regulatory Agency (MHRA)
Senior GCP Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
Deputy Director
Office of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
R
Head of GPvP and Senior Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
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)
Compliance and Enforcement Specialist
Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
S
National supervisor
Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
National Supervisor
Clinical Trial Compliance Program (CTCP), Regulatory Operations and Enforcement Branch (ROEB), Health Canada (HC)
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)
Senior Clinical Assessment Officer
Bureau of Pharmaceutical Sciences (BPS), Pharmaceutical Drugs Directorate (PDD), Health Products and Food Branch (HPFB), Health Canada (HC)
V
Head of Compliance
Standards and Compliance Team 1, Medicines and Healthcare products Regulatory Agency (MHRA)
W
Expert GCP Inspector and Head of the Compliance Expert Circle
Medicines and Healthcare products Regulatory Agency (MHRA)
Senior GCP & GLP Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
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
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)