GVP & LOCAL PV HANDBOOK TRAINING COURSE
GVP & Local PV Handbook Training Course
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.
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:
- Drug Safety
- Product Safety
- Clinical Safety
- Regulatory Affairs
- Medical Information
- Clinical Research
- Research & Development
|8:30||Welcome and Introductions|
|History and principles of pharmacovigilance, legal environment|
|Pharmacovigilance system master file and Standard Operating Procedures (SOPs), and local ‘PV handbook’|
|10:30||Case collection and reporting (sources, quality, follow-up, translation, privacy aspects)|
|Interaction with other departments (GMP, Medical affairs, Regulatory, QA, Marketing, etc.)|
|13:00||Risk 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|
|15:00||Labelling activities and public information|
|Working with external partners|
|Audits and inspections|
|16:30||Recapitulation and interactive discussion|
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.
Please complete and submit the training registration form below and we will get back to you within 24h with registration confirmation and details.