This three-day course is designed for those with at least two years’ knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company.
Key topics to be addressed:
- Audits and expectations – risk-based inspections
- Compliance and drug safety
- Overview of the PSMF in the EU
- Product safety reviews – purpose and function (incorporating the latest EU signal analysis requirements)
- Safety reporting in licensing agreements
- Developing Company Core Safety Information (CCSI) – CIOMS III
- PSURs – timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
- Implications for safety reporting in global clinical trials n Risk/benefit determinations
- Risk Management Plans (RMPs)
Benefits of attending:
- Expand your global safety knowledge
- Enhance your team’s capabilities and compliance in both the regulations and your company’s expectations
- Help ensure you build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection
- Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspections
- Discuss the implications of Brexit
Who should attend?
This course would be of maximum benefit to those safety professionals who are working both in the clinical and post–marketing safety arena including QA for auditing. The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.
Programme - Day one
- Due Diligence on products, companies (partners and acquisitions)
- Due Diligence involvement – team composition
- Safety information requirements for due diligence
- Review of safety data (clinical and post-marketing)
- Defining risk in due diligence appraisals
Training for drug safety reporting duties
- Regulations concerning safety training
- Who trains whom and when?
- Training versus job description
- Training records, maintenance and updates
- Role of QA and HR in training
Audits and expectations
- Regulatory expectations in Pharmacovigilance audits (risk-based inspections)
- Preparation for the audit
- Records to be available at the audit
- Audit findings/recommendations
Compliance and drug safety
- Basic principles – what will the regulators want to see?
- Measuring compliance
- Quality versus quantity in safety reports
- Future aspects in ensuring efficient compliance
- Quality management under the new EU legislation
The PV System Master File (PSMF)
- The PSMF – purpose and maintenance
- The PSMF annexes
- The PSMF and audits
Interactive exercise: The requirements for a safety department
Programme - Day two
Product safety reviews – purpose and function
- The Safety Review Committee (SRC)
- What to look for in signal evaluation under latest EU guidance
- Timings for safety review in clinical and post-marketed products
- Record keeping for safety review meetings
- Serious safety findings – crisis management following new safety findings
Interactive exercise: Designing the requirements for a safety review group
Safety reporting in licensing agreements
- What types of licensing agreements exist?
- What are the EU and FDA Regulations concerning licensing agreements?
- Audits of pharmacovigilance capabilities in licensing partners
- What agreements need to be in place for safety reporting?
- Safety reporting agreements – what needs to be covered?
- Monitoring safety agreements – what happens if it goes wrong?
Developing Company Core Safety Information (CCSI) – CIOMS III
- CIOMS III and CCSI
- Developmental core safety information (DCSI)
- How to determine what to include and what to exclude in DCSI/CCSI
- Are there differences in EU and FDA?
- Maintenance and development of CCSI
Interactive exercise: Should new safety data from a clinical trial be put into core safety information?
PSURs and the revisions in ICH E2C
- Timing for PSURs
- PSUR content and latest format
- Late breaking information and PSUR extensions
- The DSUR
Programme - Day three
The EU Clinical Trials Directive
- The principles of the directive
- Implications for safety reporting in global clinical trials
- The SUSAR database
- The EUDRACT database
- The new EU Clinical Trial Regulation
- Definitions of risk/benefit – FDA and EU perspective
- Risk/benefit assessments – who does this and where does the information go?
- Safety assessments and risk/benefit – frequency and reporting
- Changes in risk/benefit – how to manage and review existing profiles
Interactive exercise: Reviewing the safety and risk/benefit of a product
Risk Management Plans (RMPs)
- Monitoring and updating the RMP
- Reporting the RMP
Crisis management within drug safety
- Regulations and guidelines in connection with serious safety issues
- What determines a crisis?
- Communications to regulators – what is required?
- Communications within the company
- What happens next?
Interactive exercise: Deciding how to handle a major crisis within the company
Delegates will be split into groups and present what they need to have in place in order to effectively manage the crisis and look to its resolution.
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he 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.