QPPV in the CIS: Challenges and Opportunities November 30, 2023

QPPV in the CIS: Challenges and Opportunities

The fast-growing pharmaceutical market in the CIS countries presents a lot of opportunities for pharmaceutical manufacturers. However, it also comes with challenges.

For example, the legislative requirements for Pharmacovigilance (PV) and the appointment of QPPV or LPPV (Local Person for Pharmacovigilance) are different in the CIS countries.

The QPPV or LPPV must be appropriately qualified in PV including according to local legislation, in most cases a resident of the country with a deep understanding of local legislation and fluent command of the local language(s).

Moreover, in some CIS countries, there is no clear Pharmacovigilance legislation and requirements for QPPV or LPPV, as well as division of responsibilities between the LPPV, MAH, and manufacturer, leading to misunderstandings and challenges in the regulatory process.

  • Covers all CIS countries, eliminating the need to seek and manage partners in each country separately 
  • Acts as a local legal entity, where it is necessary, maintaining representative offices or branches 
  • Has local full-time, highly qualified, experienced, multilingual employees in CIS countries 
  • Provides personalized solutions, making your presence in the CIS markets straightforward, compliant, and efficient. 

Explore full pharmacovigilance services on Inpharmatis website - www.inpharmatis.com.