Access to a local regulatory partner and local QPPV services in Central and Eastern European countries is an essential pre-requisite to executing successful market entry and development. Grove offers a fully comprehensive outsourced solution for local pharmacovigilance services in the CEE countries.
PHARMACOVIGILANCE AND DRUG SAFETY CONSULTING
With proven success over two decades, Grove has developed a comprehensive package which meets the needs of both its individual clients and the relevant national health authorities.
For those involved in pharmaceuticals/medicines/drugs and medical devices, the pharmacovigilance service package comprises:
- QPPV (Qualified Person Responsible for Pharmacovigilance) – 24/7 service
- 24 hour cover of adverse event case processing and adverse event reporting
- Follow up of individual case safety reports
- Expedited adverse event reporting
- Assistance for interaction with competent authorities and local healthcare professionals
- Drug Safety services, including submission of PSUR (Periodic Safety Update Reports)
- Safety Data Management
- MLM (Medical Literature Monitoring)
- Continuous update on national pharmacovigilance requirements
- Risk management plan pharmacovigilance
- Pharmacovigilance training of client’s sales force
- Implementation of local SOPs
EU pharmacovigilance regulations require each marketing authorisation holder, national competent authority and EMA to operate a pharmacovigilance system. Grove provides a network of local QPPV (Qualified Person Responsible for Pharmacovigilance) experts in Poland, Hungary, Czech Republic, Slovakia, Romania, Bulgaria, Slovenia, Croatia, Latvia, Estonia, Lithuania, Serbia, Montenegro and Russia as a solution for pharmacovigilance issues at a national level. These highly skilled and continuously trained professionals provide a full range of pharmacovigilance and medical device vigilance services to enable Grove clients to maintain compliance with EU drug safety and pharmacovigilance requirements.
Our local pharmacovigilance resources are available on a 24-hour/7 day per week basis to receive notices for any safety information, safety issue or signal for your products. The local contact person reports to the client’s European qualified person responsible for pharmacovigilance activities, in accordance with the laws and regulations applicable in a country.
Grove’s local qualified personnel take the responsibility for the collection and accurate documentation of all safety information received on national level and assists with follow-up. Safety information is forwarded to the client within the timeframes and format specified in individual Safety and Medical Information Agreements. Furthermore, we undertake local MLM (medical literature monitoring) and medical scientific literature and notify clients of published information regarding the products.
Moreover, our pharmacovigilance activities at a national level cover the following areas:
- Assistance for interaction with Competent Authorities in the country
- Assistance for interaction with Ethical Committees in the country
- Continuous update on the national pharmacovigilance and regulatory requirements
- English translations of local regulations and/or Competent Authorities communication in the country (letters, emails, fax), when available only in local languages.
- Most importantly, pharmacovigilance services at a national level ensure patient safety, fulfilment of all local and national regulatory requirements and general compliance with current international guidelines for Good Pharmacovigilance Practices.