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

2023-10-27

高管变更

DUBLIN, Oct. 27, 2023 /PRNewswire/ -- 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

The WHO and Safety Reporting

CIOMS - Function and Purpose

ICH - Composition and Guidelines

Global Pharmacovigilance and Safety Standards

Definitions of Terms (ICH) used in Pharmacovigilance

Adverse reactions versus Adverse events

Serious and Non-serious - definitions

Expected or unexpected reactions or events

Expedited reporting

Global Pharmacovigilance and Safety Standards (continued)

Pharmacovigilance and its Role in Other Departments

Pharmacovigilance - Where does it fit in the Company?

Medical Information and Drug Safety

Regulatory Dept. and Drug Safety

Clinical and Drug Safety

Commercial, Marketing and Drug Safety

Clinical Drug Safety

Basic principles - key features for capturing Drug Safety data

Case Record Form Design and Data Capture

Data Management and Drug Safety - Clinical versus Safety Databases

Assessment of Individual Serious Adverse Event Reports

Post Marketing Drug Safety

Differences in Clinical and Post Marketing Drug Safety

European Marketing Safety and Causality

Post Marketing Safety in the USA

Post-Marketing Safety in Japan

Day 2

Causality Assessments in Pharmacovigilance

Assessments for Clinical Safety and Causality

Post Marketing Safety and Causality

Causality Definitions

Company versus Reporter Causality

Pros and Cons of Causality Definitions

Pre-Clinical Animal and In vitro Studies

ICH Guidelines and Animal and In vitro Studies

EU and FDA regulations and Animal Studies

Toxicity Studies

Genotoxicity, mutagenicity and Carcinogenicity Studies

MedDRA - Introductory

Background Information concerning the Introduction of MedDRA

The MSSO and MedDRA

MedDRA Coding capabilities and approaches

MedDRA Versions and Development of the Dictionary

Old Dictionaries and Data Conversion

Collecting Good Quality Safety Information

Why the need for good Quality Safety Information?

What constitutes good safety information?

Differing regulations concerning safety data collection requirements

Designing a system to collect good quality information

The Blinded Study and Safety Reporting

Definition of a Blinded Study

Blinded Studies involving Company Products, Comparator Products and Placebo

Regulations and Guidelines for Blinded Study Safety Reporting

Unblinding and Emergency Unblinding

Blinding and Biometrics

An Introduction to Medical Device Reporting

Definition of a Medical Device

Safety Reporting of Medical Devices

FDA Regulations Concerning Medical Devices and Safety

EU Regulations Concerning Medical Devices and Safety

Day 3

The Need for Capturing Pregnancy Data

Pregnancy Information Sources

Pregnancy Data Forms, data capture and appearance in Safety Reviews

Regulations concerning pregnancy data capture

Drug Safety and At-Risk Groups

Regulations and Guidelines in Connection with At-Risk Groups

Analysis of Data from at-Risk Groups

Identification of at-Risk Groups

Reporting new findings concerning at-risk groups

Medical Aspects of Liver Disease and Hepatic Adverse Drug Reactions

Basic Physiology and Definitions

Common Liver Conditions

Drug Effects on the Liver

Pharmacovigilance evaluations with Hepatic ADRs

Medical Aspects of Renal Adverse Drug Reactions

Basic Renal Physiology

Drug Induced Renal Disease

Renal Disease and ADRs

Renal Function and Dosing in relation to ADRs

Medical Aspects of Haematological and Immunological Adverse Drug Reactions

Blood Composition and Normal values

Mechanism of action of Drugs on Blood Parameters

Type A and B reactions

Medical Aspects of Cardiovascular Disease and Adverse Drug Reactions

Basic Physiology and Heart Rhythm

QT Interval Prolongation and Drugs

Cardiovascular Disease and Drugs - contraindications

Drug Induced Cardiac ADRs

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/wzsc0z

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