Since December 2019, when the SARS-CoV-2 novel coronavirus was first reported in Wuhan, China, the pandemic has infected more than 750 million people and claimed more than 6.8 million lives.
Vaccine discovery and implementation has allowed us to move forward out of the pandemic – over 13 billion vaccine doses have been administered to date.
The exceptionally fast pace of development of the vaccines, and the accelerated approval process meant the long term safety profile of the vaccine remained inconclusive. While information on the known risks is available in the Risk Management Plans (RMPs), missing information include the use in pregnancy, immunocompromised patients, patients with comorbidities, autoimmune or inflammatory diseases, and long-term safety data.
To facilitate collection of this additional safety data, the vaccines were approved globally with the provision that the Market Authorization Holders (MAHs) carry out further Pharmacovigilance activities as documented in RMPs.
Data can be collected in an unsolicited manner, but it is accepted that such data does not always contain all elements required for full assessment and can often result in inconclusive assessment. Post-authorization safety studies which are interventional can allow collection of specific data for a more accurate assessment. An additional challenge is that HCPs must try to distinguish between long term safety as associated with the vaccine, from what is long-Covid impact.
Post authorisation safety surveillance activities as per regulatory expectations are then to be performed, and for the Covid vaccines, there are specific requirement for how often such assessments are to take place. The volume of the data collected will be vast and technological solutions are required to manage collection and assessment.
How ICON can provide differentiated service in collection and assessment of such data:
As a response to the growing need for analysing ever growing data volumes and the need for increased granularity ICON has developed advanced intelligent tools used to collect, analyze, and visualize large amounts of safety data originating from different sources. The tools are designed to create dashboards, charts, and reports that display relevant information in a easy-to-understand format.
- Post-marketed signal detection utilizing MAH specific data and data from public databases, literature
- Technical solution for data assessment via a data visualisation tool
- Tracking of signals and Risk Minimization Measures
- Aggregate data review and summary in aggregate safety reports - facilitate drafting and submission
- Post-authorisation safety studies conducted by the vaccines’ manufacturers, as required by regulators, as well as other longitudinal observational studies that complement knowledge from clinical trials
In this webinar participants will learn about:
- The Clinicians perspective and insight of Covid cases, long-Covid, challenges with sharing their observation, and their understanding of the need for this information
- Big Data - the challenges and solutions in collection and assessment of the vast volume of data associated with Covid
- Regulatory expectation for MAHs for post-authorization safety surveillance of Covid vaccines
Director Patient Safety, Pharmacovigilance & Patient Safety, ICON
Robina Azam has over 18 years’ experience in Pharmacovigilance inclusive of signal detection/safety surveillance, aggregate reports, risk management and submission related activities. Experience is inclusive of pre- and post-marketed product, from case processing, clinical study support through to aggregate report generation and signal detection. As a Patient Safety Expert, Bobby provides guidance to project teams and serves as a subject matter expert in safety surveillance and signal detection. She oversees and participates in initiatives to improve these processes, particularly to implement technological solutions to automate processes such as signal detection.
Senior Director Pharmacovigilance and Patient Safety, ICON
Rakan Bitar has over a decade's experience of building and applying expertise in the pharmaceutical industry, with a focus on patient safety and risk management. Rakan is dedicated to bringing digital innovation to drug safety and clinical development and is an automation evangelist.
Dr. Elsa Garcia Lopez
General Practitioner, The Westbourne Grove Medical Centre
Dr Elsa Garcia Lopez has over 25 years of experience as a clinician. After finishing her training as a General Practitioner in Madrid, Spain, she moved on to a consultant role in A&E in a large teaching hospital. There she gained more clinical experience in addition to training and supervising young doctors. For the last 14 years, she has been working as an NHS GP in London. During the Covid-19 pandemic, she worked as well at the local Covid hub attending to patients with Covid from different GP practices. She came into contact with the pharmacovigilance field in 2021 when she became a member of the Adjudication Committee in the context of the development of a COVID-19 vaccine.
This webinar will benefit those involved in drug safety, pharmacovigilance, regulatory affairs and medical affairs with relevant areas of expertise and job titles, including:
- Drug Safety and Pharmacovigilance Professionals
- Head of PV
- Safety Operations Leaders
- Safety Risk Management
- Patient Safety Specialists
- Qualified Persons for Pharmacovigilance (QPPV)
- Safety Scientists
- Medical Affairs Leaders
- Regulatory Affairs Professionals
- Innovation Leaders
- Scientific Officers
- Medical media professionals