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.
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.
Overall 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.
Key Topics Covered:
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
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
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/rl4smy
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