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GVP & Local PV Handbook Training Course

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Where: TonyResort, Anupriskiu k. 2, Trakai district, Lithuania

This intense single day training course is a comprehensive solution to gain and improve knowledge in pharmacovigilance and Good Pharmacovigilance Practices (GVP). The training is focused on current legal requirements, pharmacovigilance processes and systems, management of safety information, various interactions between company departments, handling for audits and inspections and more. This course will enhance your confidence and competence throughout the drug safety process.

Learning Objectives

After completing this training participants shall:

  • Understand the current legal requirements and the continuously developed GVP guidelines

  • Learn how to establish comprehensive pharmacovigilance systems and assure compliance

  • Expand knowledge on the practical aspects of pharmacovigilance processes

  • Be ready and prepared for handling pharmacovigilance audits and inspections

Who Should Attend

This training is designed to support the continuous improvement of relevant pharmacovigilance skills, scientific progress and professional development. Particularly the training course is dedicated for professionals involved in:

  • Pharmacovigilance
  • Drug Safety
  • Product Safety
  • Clinical Safety
  • Regulatory Affairs
  • Medical Information
  • Clinical Research
  • Research & Development

Trainer

ARTHUR P. MEINERS, PHARM D.
After studying medicine Arthur specialized and worked as internist and Nephrologist for 10 years. He joined the Dutch Medicines Evaluation Board in 1991 as senior medical assessor. In 1993 he started setting up the pharmacovigilance department at the Dutch Medicines Evaluation Board and headed this department from 1995 to 2001. From 1995 to 2000, Arthur was the national coordinator for pharmacovigilance, the Pharmacovigilance Working Party member for the Netherlands. He was also a member of the ICH E2B working group and was involved in the development of MedDRA. In 2001 Arthur joined Johnson and Johnson as senior medical advisor and Qualified Person for Pharmacovigilance (QPPV), and since 2010 he has acted as a PV consultant. With comprehensive PV experience, strategic views and strong team building skills he is an asset to any organisation both hands on and strategically. Arthur enjoys sharing his knowledge and draws on this experience to deliver entertaining and enlightening training programmes.

Course Agenda

8:00Registration
8:30Welcome and Introductions
History and principles of pharmacovigilance, legal environment
Pharmacovigilance system master file and Standard Operating Procedures (SOPs), and local ‘PV handbook’
10:00Coffee break
10:30Case collection and reporting (sources, quality, follow-up, translation, privacy aspects)
Interaction with other departments (GMP, Medical affairs, Regulatory, QA, Marketing, etc.)
12:15Lunch
13:00Risk management plans, risk minimization activities, other commitments, their implementation, and compliance tracking
Other post-marketing activities (e.g. Patient support programs, market research activities) and PV
14:30Coffee break
15:00Labelling activities and public information
Working with external partners
Audits and inspections
16:30Recapitulation and interactive discussion
17:00End

Price

List Price:     €800 per participant

Training handouts, lunch, coffee and snacks are included.

Group discounts apply for several participants delegated from the same company. Please contact us for more information.

Course Registration

Please complete and submit the training registration form below and we will get back to you within 24h with registration confirmation and details.

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