Pharmacovigilance Under COVID-19 – Webinar Recording/Transcript
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The COVID-19 crisis has changed nearly every aspect of the pharmaceutical clinical trial, approval and postmarket surveillance process. Both the FDA and EMA have issued recent guidance around the actions pharmaceutical companies should take during the pandemic and which compliance expectations apply.
The Pharmacovigilance Under COVID-19 presentation on Nov. 19 will go through best practices around resource reductions, safety reporting, labeling, compliance documents and reporting adverse events. Through the insights of the expert speaker, you’ll discover how to best move forward with your clinical trial during the challenging times of this global health pandemic.
Pharmacovigilance expert Dr. Graeme Ladds, CEO, PharSafer Associates Ltd., will share practical tips on interpreting pharmacovigilance legislation, regulations and guidance. Dr. Ladds will also update you on what regulators expect to see from drug companies through the COVID-19 crisis.
- Develop best practices for prioritizing product risks and communicating those risks to regulators during the COVID-19 pandemic
- Comply with expedited reporting rules during the health crisis
- Create world-class SOPs, including those that contain exceptions to accommodate COVID-19 issues
- Construct real-world timelines that take into account compliance requirements around COVID-19
- Record and document deviations from normal requirements to satisfy regulators, especially regarding adverse events
You need to know best practices and stay compliant with current safety reporting, labeling and reporting. This expert webinar will ensure you have the knowledge you need to push forward a compliant product during these difficult times.
Meet Your Presenter
Dr. Graeme Ladds, CEO of PharSafer Associates Ltd., has spent that last 30 years in pharmacovigilance, holding several senior positions at global top 10 pharmaceutical companies. Dr. Ladds is a specialist focused on global clinical and postmarketing pharmacovigilance. Before creating the PharSafer® and SaPhar brands, he was head of global drug safety for a multi-national pharmaceutical company and EU qualified person for pharmacovigilance (EU QP PV). During his long career in drug safety and medical services, Dr. Ladds has partnered with a global safety database provider to design a validated global medical information database, which linked directly to the safety database.
Who Will Benefit
- Pharmaceutical companies
- Regulatory specialists
- Compliance professionals
- Quality specialists
- GMP professionals
- Inspections and audit staff
- Postmarket safety teams
- Submissions and approvals staff
- Research and development professionals
- Commercial operations staff
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Nov. 19, 2020