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Thursday, June 17 • 12:00pm - 1:00pm
#501 OD: Safety Compliance

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Component Type: Session
Level: Intermediate

This session will provide an update on key topics related to compliance with pharmacovigilance regulations, including information on inspection findings and procedures in general and with a specific focus on risk management, as well as the broader compliance implications of Clinical Trial Regulation.

Learning Objectives

Examine how a risk-based approach leads to more efficient PV; Identify the systems gaps that have been revealed by inspections; Describe practical ways to globally harmonize PV and GCP compliance; Assess MHRA inspection Metrics and find the prominent areas of the risk management system which lead to critical and major findings.

Chair

Alan M Hochberg

Speaker

MHRA GPvP Inspections: Trends in Compliance and Evolution of Inspections
Mandy Budwal-Jagait, MSc

Clinical Trial Regulation is an Opportunity to Revisit Compliance at the Pharmacovigilance and GCP Interface
Shelley Gandhi, MSc

Risk Management System: An Area of Specific Concern : Analysis of MHRA GPvP Inspection Metrics Reports from June 2009-March 2020
Garima Mishra, MPharm


Speakers
avatar for Alan Hochberg

Alan Hochberg

Principal Scientific Enablement Director, F. Hoffmann-La Roche, Switzerland
Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engineering... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
avatar for Garima Mishra

Garima Mishra

Senior Pharmacovigilance Associate, APCER Life Sciences, India
Garima Mishra is a Senior Pharmacovigilance Associate in APCER Life Sciences, with overall experience of 4.5 years in Pharmacovigilance. In her current role, she is associated with risk management department wherein she is involved in maintenance of risk management plans and tracking... Read More →
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP and Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →

Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   20: Early Access Content, Session