Advanced Pharmacovigilance

This course is designed for those with at least two years worth of knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company pharmacovigilance Inspection.

KEY TOPICS TO BE COVERED

• Training for Drug Safety Reporting Duties, Audits and Expectations Risk Based Inspections
• The DDPS retirement and the New PV Master file in the EU
• Compliance and Drug Safety
• Product Safety Reviews Purpose and Function (incorporating the new EU Signal Analysis Requirements)
• Developing Company Core System Information CIOMS III
• Safety Reporting in Licensing Agreements
• PSURs Timing, Content and the DSUR and the New ICH E2C (2nd Revision requirements)
• Implications for Safety Reporting in Global Clinical Trials
• Risk/Benefit Determinations
• Risk Management Plans

• 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 inspection

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

09.00 Registration and Coffee

09.30 Start of meeting

Due Diligence

• Due Diligence on products, companies (partners & 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 and 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 Master File and the DDPS

• The PV Master File
• The PV Master File – purpose and maintenance
• The DDPS – What happens now
• Transition from DDPS to PV Master File

Interactive Exercise: Designing the Requirements for a Safety Department and Drug Safety

17.00 Close of day one

09.00 Start of day two

Product Safety Reviews – Purpose & Function

• The Safety Review Committee
• What to look for in signal evaluation under new 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 & 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 – CIOMS III

• CIOMS III & Core Safety Information
• Developmental Core Safety Information (DCSI)
• How to determine what to include, what to exclude in DCSI/CCSI
• Are there differences in EU and FDA?
• Determinations of inclusion in CCSI
• Maintenance & development of CCSI

INTERACTIVE EXERCISE: Deciding whether New Safety Data presented from a Clinical Trial should be put into Core Safety Information

PSURs and the New Revisions in ICH E2C

• Timing for PSURs
• PSUR Content – and new format
• Late breaking information and PSUR extensions
• The DSUR

17.00 Close of day two

09.00 Start of 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

Risk/Benefit Determinations

• Definitions of risk/benefit – FDA and EU perspective (including the new 2012 legislation)
• 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 of a Product

Risk Management Plans (including new EU requirements 2012)

• Purpose
• Content
• Monitoring and updating the RMP
• Reporting the RMP

Crisis Management within Drug Safety

• Regulations & 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

16.30 Close of day three

Graeme Ladds

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, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. The last 12 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, 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.

• Alvogen Romania SRL
• Andrew Boshier
• Aspen Pharma Trading Ltd
• Astellas BV
• Astellas Pharma A/S
• Basilea Pharmaceutica International Ltd
• Boehringer Ingelheim Ilaç Tic. A.S.
• CEREXA INC
• Certor bvba
• Genus Pharmaceuticals Ltd
• GlaxoSmithKline
• HAL Allergy BV Leiden
• Janssen
• Janssen Pharmaceutica NV
• Janssen-Cilag Ltd
• Johnson & Johnson
• Johnson & Johnson Consumer Services EAME Ltd
• Norgine Ltd
• Nycomed UK Limited
• Pierre Fabre Medicament
• Qualitis
• Rosemont Pharmaceuticals Limited
• Sandoz Limited
• Sanofi-aventis AB
• Saudi Food and Drug Authority
• Schwarz BioSciences GmbH
• Spectrum Regulatory Solutions
• Takeda Development Centre Europe Ltd
• Takeda Pharmaceutical Company Ltd
• UCB Pharma Limited