Research and Markets (http://www.researchandmarkets.com/research/mzztht/a_practical) has announced the addition of the "A Practical Approach to Pharmacovigilance and An Essential Guide to Medical Information" conference to their offering.
Pharmacovigilance has become one of the most demanding aspects for licence holders to both understand and comply with. There are many requirements for companies to perform regarding the safety of their products to satisfy regulatory demands and sanctions for non compliance can be severe. The new Pharmacovigilance Legislation requires companies to train all staff, including those not working directly in Pharmacovigilance and this course will meet that requirement and help explain what you need to know in terms of your pharmacovigilance responsibilities.
Topics to be covered will include:
- An Introduction to EU Pharmacovigilance
- Documentation to be Supplied to Regulatory Authorities
- Department Links in the Company to Pharmacovigilance
- Licensing Partners and Pharmacovigilance
- The Role of the Qualified Person for Pharmacovigilance
- Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance
- Pharmacovigilance Inspections
An Essential Guide to Medical Information
This course is intended for those that answer medical enquiries as part of their daily work as well as new full time medical information specialists who are starting their career in medical information.
The course will go through some basic aspects and explain both the legal requirements for a medical service in Europe as well as practical aspects of how to provide an efficient medical service with linkage to other areas such as Marketing, Regulatory and Drug Safety.
Key topics to be covered:
- Understand the Role of Medical Information
- What are the Legal Requirements for a Medical Information Service?
- Discuss Standard Responses, FAQs and Complex Questions
- Clarify the Guidelines for Medical Information & Advertising
- Receive Practical Advice on Black Triangle Products & Additional Monitoring
For more information visit http://www.researchandmarkets.com/research/mzztht/a_practical
