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.
Certifications:
- CPD: 18 hours for your records
- Certificate of completion
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
Mr 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.
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.
