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3 Day Online Course: Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors – Broadening your Knowledge Training Course (January 31, 2024 February 2, 2024) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors – Broadening your Knowledge Training Course” conference has been added to ResearchAndMarkets.com’s offering.


This course will provide a thorough and extensive overview of pharmacovigilance and will equip delegates with the ability to apply the knowledge gained to enhance their role within the company.

The importance of drug and medical device safety is paramount and the regulations and requirements applicable to the discipline of pharmacovigilance are extensive and complex.

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to learn next in this complex area.

It will give a comprehensive overview of all aspects of PV from global pharmacovigilance and safety standards to where drug safety fits within the company. Safety reporting, adverse reactions vs adverse events, and clinical drug safety will be addressed. It will introduce Medical Device reporting and look at both EU and FDA regulations. Pre-clinical animal and in-vitro studies will also be covered as will post-marketing drug safety. How to collect quality data and specific clinical areas such as Pregnancy and At-Risk Groups will be discussed.

Who Should Attend:

This course is suitable for Pharmacovigilance (PV) personnel with up to 24 months of experience, looking to diversify their knowledge and expand their potential to move into different areas of Pharmacovigilance.

The course would also be appropriate for Auditors who want to understand more about PV and what to look out for when performing audits.

It would also be beneficial to Regulatory Affairs personnel who want to understand some of the pharmacovigilance activities that cross over into the Regulatory area.

Agenda:

Day 1

Background and Introduction to Pharmacovigilance

Global Pharmacovigilance and Safety Standards

Global Pharmacovigilance and Safety Standards (continued)

Pharmacovigilance and its Role in Other Departments

Clinical Drug Safety

Post Marketing Drug Safety

Day 2

Causality Assessments in Pharmacovigilance

Pre-Clinical Animal and In-vitro Studies

MedDRA – Introductory

Collecting Good Quality Safety Information

The Blinded Study and Safety Reporting

An Introduction to Medical Device Reporting

Day 3

The Need for Capturing Pregnancy Data

Drug Safety and At-Risk Groups

Medical Aspects of Liver Disease and Hepatic Adverse Drug Reactions

Medical Aspects of Renal Adverse Drug Reactions

Medical Aspects of Haematological and Immunological Adverse Drug Reactions

Medical Aspects of Cardiovascular Disease and Adverse Drug Reactions

Speakers:

Graeme Ladds

Director

PharSafer Associates Ltd.

Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

For more information about this conference visit https://www.researchandmarkets.com/r/vefy4s

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