Latest Developments in Pharmacovigilance

Covering Latest Developments and Hot Topics – consolidate your understanding of the issues that challenge companies in the current regulatory environment

Course overview

This advanced course has been specifically designed to provide an update on the latest developments impacting on your role whether you work in pharmacovigilance or an associated function. In particular it will look at the progress with the ‘new’ EU legislation, how it is being interpreted and implemented by industry, the regulators and inspectors.

The programme will include discussion and interpretation of the most current EU legislation as well as covering topical current issues relevant to pharmacovigilance. There will be ample opportunity throughout the two days for discussion, tips and practical advice from the expert speakers and co-delegates. You will also be welcome to contribute your own experiences.

The programme will also cover core topics, with the topic selection based on areas of pharmacovigilance where inspection findings commonly occur. Delegates will also be offered some ‘hot topics’ that have been in the news recently. Your input will be requested prior to the course to decide what topics are included in the final agenda.

Who should attend

This interactive course will benefit you if you are involved in the daily practice of pharmacovigilance and are looking for an update on the latest developments and current ‘hot topics’.

It will also benefit those in departments working closely with the pharmacovigilance department, such as regulatory, clinical, medical information or quality. It will help you understand what they are asking for from you and why, enabling you to work more effectively with them.

Programme day one

The following core topics will be covered:

GVP Module I and Quality System – approaches and challenges

  • The meaning of ‘system oversight’and how to achieve it
  • KPIs and Metrics – what to measure, how to measure and what to include in the PSMF
  • Management of noncompliances, deviations and CAPAs
Safety Monitoring and Signal management
  • GVP Module IX, CIOMS VIII • What is practical, what is appropriate – does one size fit all?
  • Signal tracking and associated timelines
PSMF
  • Summary of the PSMF
  • Maintenance and update issues • Inspection findings relating to the PSMF
Update on Global PV Regulations
  • The “New” EU legislation – progress and status
  • GVP Module updates
  • What is happening in the US?
  • How does this fit with RoW?
Compliance
  • Discussing areas where companies have encountered difficulties:
    • Post marketing studies and PASS
    • Patient data collection programs
    • Risk minimisation – Global and Local activities
    • PSMF
    • Your issues

Programme day two

Your input will be requested prior to the course to select the topics of most value to delegates. Select from the following topics or please propose a topic or focus of your own.

Please note that it may not be possible to include all topics proposed.

QPPV oversight
  • The responsibilities of the QPPV
  • The relationship between the QPPV and the MAH – contract terms and respective responsibilities for ongoing safety management
  • The QPPV and GVP Module 1

Risk Management

  • GVP V update and the new template
  • Innovative products, generics and others
  • The relationship with signal management and PSURs
  • Challenges for RMPs and effectiveness of measures

Pharmacovigilance Inspections

  • Feedback and trends

Reference Safety Information

  • What are regulatory authority expectations?
  • How do PhV and Regulatory ensure effective communication?
  • Relationship with PSURs & RMP
PSURs and PBRERs
  • Global harmonisation?
  • The PSUR repository
  • Practical aspects

Literature – Global and Local requirements

Case Management

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

You may also be interested in