The new EU legislation concerning pharmacovigilance comes into effect in July 2012. Together with tighter supervision by the Belgian Federal Agency for Medicines and Health Products (FAMHP) in this area, Marketing Authorisation Holders should take the following important matters into consideration during the coming months.
All Pharmaceutical Companies need to rely on a qualified person for pharmacovigilance. It is of the utmost importace that this person has a good overview of the company-specific situation.
Archemin has extensive experience in these matters and can guide Pharmaceutical Companies through the following challenges:
- the training of their newly appointed contact person and the training required by law of all employees concerning pharmacovigilance.
- the development of a tailor-made quality system for pharmacovigilance, including a set of procedures in accordance with the latest “Guidelines on Good Pharmacovigilance Practice”.
- the conversion of existing “Detailed Description of the Pharmacovigilance Systems” to a “Pharmacovigilance Master File” that meets the current legal requirements.
- the implementation of independent audits aimed at improving the existing pharmacovigilance system and ensuring that it meets all legal obligations.
- guidance during periodic (self) inspections of the functioning of the system for pharmacovigilance.
- preparing and guiding the Marketing Authorisation Holder in the case of inspections by government authorities
- compilation of Periodic Safety Update Reports, a Risk Management Plan (compulsory for each new registration application) and (updating of) Clinical Overviews for pharmaceutical products
- the organisation of a Post-Approval Safety Study
Of course Archemin's clients can rely on the professionals of the Pharmacovigilance team for the following routine tasks:
- the collection, analysis and centralisation of adverse effects in a specifically designed database
- the reporting of these adverse effects to the competent authorities
- literature monitoring (English, French, Dutch, ...)
- 24 / 7 permanence