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Thursday, June 18 • 5:00pm - 6:00pm
#545 OD: ON DEMAND - Clinical Safety: Approaches to Assure Compliance in the Pharmacovigilance and GCP Interface

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Component Type: Session
Level: Intermediate

Safety for subjects participating in clinical trials is paramount. Regulatory reporting requirements that are in place around the world facilitate the timely notification of regulatory authorities, sponsors, investigators and ethics committees to ensure that that emerging risks are identified swiftly and that trial subjects are protected. Once a product is granted authorization, pharmacovigilance requirements apply to ensure patients are protected and, if interventional studies are ongoing, clinical trials requirements continue to apply to ensure protection for trial subjects. This session will look at novel approaches to efficiently fulfilling safety reporting requirements for clinical trials. The session will also examine the interfaces between pharmacovigilance and clinical trials, and how strong relationships between pharmacovigilance and clinical functions can achieve a more proactive approach to protecting both patients and trial subjects.

Learning Objectives

Describe the interfaces between pharmacovigilance and GCP; Identify tools for building practical relationships between pharmacovigilance and GCP to better protect patients and trial subjects; Recognize effective processes for ensuring timely safety reporting to regulatory authorities and other concerned stakeholders to ensure trial subjects are protected in real-time.

Chair

Anna Adams, PhD, MSc

Speaker

The Need to Focus on the GCP/PV Interface to Improve Compliance, Data Integrity, and Confidence in Inspection Readiness
Shelley Gandhi, MSc

Precision Global Safety Reporting in Clinical Trials According to Local Rules and Industry Standards
Steven Beales



Speakers
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 Steven Beales

Steven Beales

Senior Vice President, Scientific and Regulatory Review, WIRB-Copernicus Group (WCG)
Steven Beales, WCG’s Senior Vice President of Scientific and Regulatory. An expert in the field of safety reporting technology, Mr. Beales has 25 years of experience in IT, and has spent over 16 years in the pharmaceutical industry. He joined WCG ePharmaSolutions in 2009 and led... Read More →
avatar for Anna Adams

Anna Adams

Senior GPvP Inspector, Inspection, Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA)
Anna joined the MHRA as a Pharmacovigilance Inspector at the start of 2016. Since then, she has inspected the pharmacovigilance systems of all types of pharmaceutical organisations from large innovator firms, to small biotech start-ups, to international organisations with established... Read More →
avatar for Steven Beales

Steven Beales

Senior Vice President, Scientific & Regulatory Review, WCG
Steven Beales is the SVP of Safety Reporting at WCG and co-chair of the Safety Reporting Reference Model working group. Steven has led the implementation of Clinical Trial Safety Portals for over 100 countries, working with 1 each of the top 3 Pharmaceutical, Biotech and CRO companies... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044