LPPV & Local Safety Personnel.
Full national/local compliance support.

What are LPPVs, LCPPVs, LSOs, LDSRs & Regional Representatives?

The need for Local Safety roles.

LPPVs and Local Safety Personnel are a national level extension to the obligations of Marketing Authorization Holders (MAHs) operating within the European Economic Area (EEA).

MAHs must designate a European Union Qualified Person for Pharmacovigilance (EU QPPV) to establish and maintain their pharmacovigilance (PV) system. EU QPPVs assume personal legal responsibility for the safety of the products held by the MAH, serving as the registered point of contact for both the European Medicines Agency (EMA) and National Competent Authorities (NCAs). They are also required to be registered in either/both EudraVigilance or EVVet and must reside and operate within an EEA member country.

But in several countries, there are also legal requirements for different local in-country safety personnel in addition to the EU QPPV. The requirements and legal responsibilities of the EU QPPV role are specified within EU legislation, but the differing local safety roles are subject to specific national legislation.

Click for more information from the EMA on National Pharmacovigilance Contact Requirements.

Local Safety Personnel titles.

Depending on both national capability requirements and a MAHs requirements, local safety role and responsibilities may go by various titles, including:

  • Local Person for Pharmacovigilance (LPPV).
  • Local Contact Person for Pharmacovigilance (LCPPV).
  • Local safety officer (LSO).
  • Drug Safety Officer (DSO).
  • Local drug-safety-responsible officer (LDSR).

 

Veterinary Regional Representative.

There is also a requirement for a similar role within Veterinary Pharmacovigilance known as the ‘Regional Representative’, responsible for overseeing a Marketing Authorization Holder’s (MAH) Veterinary Medicinal Products at the national level, and liaising with National Competent Authorities (NCAs).

What are the typical safety-related tasks at the local level?

The primary goal for all these roles remains consistent: to have a dedicated, well-informed, and efficient technical representative operating at the national level.

They must have a thorough understanding of current and evolving local regulations, dedicated to mitigating risks and ensuring the compliance of your products.

The typical tasks performed by local safety representatives include, but are not limited to:

  • Receiving and processing Individual Case Safety Reports (ICSRs) at the local level.
  • Managing local submissions such as aggregate reports, Risk Management Plans (RMPs), and additional ICSRs.
  • Monitoring compliance with local regulations.
  • Implementing additional Risk Minimization Measures (aRMM).
  • Meeting local pharmacovigilance requirements within applicable procedures and systems.
  • Providing training specific to pharmacovigilance and product safety.
  • Preparing for and participating in Health Authority inspections.

How Aegisana’s Local Safety Personnel services can support you?

A full local service.

The Pharmacovigilance team at Aegisana has a deep understanding of the specific safety mandates within the EEA regarding LPPVs and Local Safety Personnel. We have an established network of fully qualified partners who undergo rigorous evaluation through our risk-based vendor audit and management program.

Each partner adheres to our own Standard Operating Procedures (SOPs) and Quality Management System, or they can align with your procedures, ensuring comprehensive compliance oversight and control.

Efficient & consistent.

Our local pharmacovigilance services and solutions are built upon principles of efficiency, robust communication, and unwavering consistency throughout your collaboration with us.

Regardless of the complexity of your requirements, we have the capability to deliver efficient and effective pharmacovigilance solutions to meet your needs.