Overview of Pharmacovigilance Under COVID-19

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

COVID constraints placed great strains upon the Pharmacovigilance reporting requirements as staff were working remotely or sick with the COVID illness.

Recognising such constraints the Regulatory Agencies have provided temporary contingencies for reporting pharmacovigilance reports and documentation. These guidances ‘relax’ some of the reporting requirements for pharmacovigilance but do not explain how and what should be done for recording these extraordinary events as Companies record compliance activities for this period of time as well as deviate from present processes.

The 90-minute talk covers these aspects and what items can and cannot be relaxed.

Hear by top Pharmaceutical speaker Graeme Ladds who has been involved in training courses and presenting on a variety of pharmacovigilance topics of all complexities for nearly the last 20 years globally. In that time he has trained face-to-face over 5000 safety professionals and over 1000 people via video remotely.

For Pharmacovigilance and QA personnel, this course aims to demonstrate what the new guidances allow in terms of pharmacovigilance activities that can be relaxed during COVID and how to achieve these exemptions while achieving compliance and noting any deviations to existing processes and training.

What the USA regulations are for COVID pharmacovigilance for:

• Periodic reporting
• Expedited reporting
• What the EU Regulations are for COVID pharmacovigilance
• Periodic reporting
• Expedited reporting
• Some items that are to be reported irrespective of COVID guidances
• What needs to be documented during the deviation period with COVID

The following personnel should attend the course:

• Pharmacovigilance personnel
• QA Personnel
• Regulatory Affairs Personnel
• Compliance Officers

https://worldcomplianceseminars.com/p/post-market-activities-in-the-eu-mdr-a-detailed-analysis

CEO PharSafer Associates Ltd - Global Leaders in Drug SafetyEngland, United Kingdom

With a first degree in Biochemistry & Pharmacology and a PhD focussing on drug metabolism and Pharmacokinetics Graeme has worked in the areas of Drug Safety and Medical services for nearly the last 30 years.

Graeme has been working as Head of Global Pharmacovigilance and EU QP PV for many large (and small) Pharma, and has been CEO for the last 17 years for PharSafer.

Graeme is also a member of TOPRA; RQA and the Institute of Directors and has helped small start up Companies in their planning, growth and been involved in Company acquisitions, due diligence activities for product in-licensing and marketing and development strategies.