Presented by
Management Forum
Clinical & Post-Marketing Safety In-house Training
This two-day course covers international standards for clinical and post-marketing drug safety, including ICH guidelines, adverse event reporting, signal detection, and risk management strategies.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
This two-day course on provides a comprehensive overview of international standards and best practices in drug safety monitoring. Day 1 focuses on Clinical Safety, covering pre-clinical safety, ICH E guidelines for safety data capture, adverse event reporting, and risk management strategies in clinical trials. Participants will gain insights into signal detection, investigator brochure requirements, and regulatory obligations across trial phases. Day 2 shifts to Post-Marketing Safety, addressing ICH E2D standards, post-marketing vigilance, safety information updates, and risk mitigation strategies.
This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.
Benefits of attending
- Gain a comprehensive understanding of clinical and post-marketing drug safety regulations
- Learn ICH guidelines for safety data capture, adverse event reporting, and risk management
- Enhance your ability to detect safety signals in clinical trials and post-marketing surveillance
- Understand regulatory obligations across different trial phases and post-authorisation
- Improve your skills in developing risk management plans and mitigation strategies
- Stay updated on global pharmacovigilance standards and best practices
Who should attend?
Professionals working within these industries, who want a comprehensive introduction, will benefit from this engaging course:
- Clinical
- Pharmacovigilance
- Regulatory
This course will cover:
Clinical safety – international standards (ICH)
- Pre-clinical safety – the precursor to human safety
- ICH E Standards for safety data capture and reporting
- Phases I–III for safety monitoring
- Phase IV safety obligations
ICH EA individual (serious) adverse event data capture and reporting
- ICH E2A – definitions of (serious) adverse events
- What data needs to be captured
- Safety data reporting requirements (expedited)
- National variations on ICH E2A
Safety information and the Investigator Brochure (IB)
- ICH E6 (R3) and the IB
- What safety information is required in the IB
- Safety updates to the IB
- Safety expectedness and the IB
Safety information and the protocol (ICH E6 R3)
- What safety information needs inclusion in the protocol
- Special product specific ADRs
- Pregnancy exposure safety information
- Special safety information in clinical trials
Signal detection in clinical trials
- Definitions of what is a signal
- Regulatory requirements for safety signal analysis
- The role of the IDMC/DSMB
- Class related signals
Risk Management Plans (RMPs) and mitigation strategies from clinical trials
- The Risk Management Plan (RMP)
- Risk minimisation activities
- The post-authorisation safety/efficacy study
- Monitoring for ‘special’ ADRs
Post-marketing safety – International Standards (ICH)
- Post-marketing safety reporting – the precursor to human safety
- ICH E standards for safety data capture and reporting (ICH E2D (R1))
- Early post-marketing vigilance standards
- Phase IV safety obligations – monitoring and reporting
ICH E2D individual (serious) adverse event data capture and reporting
- ICH E2D – definitions of (serious) adverse events
- What data needs to be captured
- Safety data reporting requirements (expedited)
- National variations on ICH E2D (serious and non-serious case reporting)
Safety information and the Summary of Product Characteristics (SPC)/product monograph
- Expectedness vs. listedness – the difference?
- The SPC vs. Core Safety Information (CSI)
- Safety updates to the SPC for innovator and generic products
- Safety expectedness and the SPC/CSI
Safety information and post-marketing studies
- The Post-Authorisation Safety Study (PASS)
- The Periodic Benefit-Risk Evaluation Report (PBRER) (ICH E2C (R3))
- Special product specific ADRs
- Pregnancy exposure safety information
- Special safety information in clinical trials
Signal detection in post-marketing products
- Definitions of what is a signal?
- Regulatory requirements for safety signal analysis for post-marketing
- The role of the regulators and Pharmacovigilance Risk Assessment Committee (PRAC)
- Class related signals
Risk Management Plans (RMPs) and mitigations strategies from post-marketing
- The Risk Management Plan (RMP) and updates
- Risk minimisation activities and updates
- The post-authorisation safety/efficacy Study – filling in the gaps
- Monitoring for ‘special’ ADRs – where do updates appear?
Graeme Ladds
PharSafer Associates Ltd
Graeme is Director of PharSafer and has over 30 years’ experience working in the pharmaceutical industry, having started his career at Ashbourne Pharmaceuticals as Head of Drug Safety and Medical Information. Graham has a wealth of experience establishing pharmacovigilance within companies.
Run Clinical & Post-Marketing Safety Live online for your team
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
