PHARMACOVIGILANCE

Specialist Support Outsourcing

Assessment of benefit-risk

The EU regulations and Guideline on Good Pharmacovigilance Practices require companies to continuously monitor the benefits and risks of their marketed medicines. This involves various activities requiring pharmacovigilance experience and expertise including:

Data Safety Monitoring Boards

A Data Safety Monitoring Board, or Data Monitoring Committee (the terms are used interchangeably), is a committee used to monitor safety in clinical trials. They enable safety monitoring to be carried out while maintaining the blinding of the trial so that the blinding is not broken and the trial remains valid.

Pharmacovigilance Process Development

The Good Pharmacovigilance Practice (GVP) modules and other drug safety regulations set out exacting standards for you to meet without exception and the quality documentation required for your systems and activities is extensive and specified in GVP Module I. Due to the level of complexity, most companies find they face challenges e.g.:

Responding to regulator safety enquiries

When regulatory authorities have questions about the safety of your products or about the effectiveness of your pharmacovigilance system, you had better be able to come up with the answers. And who better to help with the response than PrimeVigilance experts and pharmacovigilance consultants who have “sat on the other side of the table”?

Risk Management Plan in Pharmacovigilance

All applications for marketing authorisation in the EU must include a detailed and complex Risk Management Plan (RMP). In addition, renewals for older or generic products require an RMP.

Safety Concerns and Safety Communication

Reports of issues regarding the safety of your medicinal products may come in from many different sources. Most pharmacovigilance professionals expect spontaneous reports to come in from GPs and regulatory authority but there are other sources:

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+44 (0)1483 307920
+1 792 3740

LOCATIONS

United Kingdom (Head Office)

PrimeVigilance Ltd
1 Occam Court
Surrey Research Park
Guildford, Surrey
GU2 7HJ

USA

PrimeVigilance USA Inc.
5430 Wade Park Blvd.
Suite #208
Raleigh
NC 27607 USA

Croatia

PrimeVigilance Zagreb d.o.o.
Oreskoviceva 20A
10020 Zagreb

Germany

PrimeVigilance GmbH
Herriotstr. 1,
60528,
Frankfurt am Main

Czech Republic

PrimeVigilance s.r.o.
Stetkova 18
140 00 Praha 4

Serbia

PrimeVigilance d.o.o. Beograd
Đorđa Stanojevića 14
11070 Novi Beograd

Poland

PrimeVigilance –
Ergomed Sp. z.o.o.
Ul. Armii Krajowej 18
30-150 Krakow

Japan

PrimeVigilance Japan K.K.
3-1-6 Motoazabu, Minato-ku,
Tokyo, Japan