Risk Management Activities

Risk management and minimisation activities can include post-authorisation safety studies (PASS), review of the effectiveness of risk minimisation measures, monitoring pharmacovigilance risk assessment committee (PRAC) recommendations for signals and addressing PRAC safety related queries.

A risk management system is a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions (EMEA/CHMP/96268/2005)

Regulink’s PV specialist will help with your risk management and minimisation activities:

Signal detection process set up
Signal management
CCSI, SmPC and PIL updates due to signal detection
Eudravigilance Data Analysis System (EVDAS) set up (e.g. black triangle products, PASS studies product, rare disease etc.)
PASS support for PV activities
Interim and final PASS study report reviews
Review risk minimisation activity effectiveness
Monitoring of PRAC recommendations for signals
Addressing safety related queries from PRAC recommendations

OTHER PHARMACOVIGILANCE SERVICES

Whether it be the longer term engagement of a contract QPPV or specific pharmacovigilance activities, Regulink is here to support you in meeting your post-authorisation and clinical trial needs. From case processing to periodic reporting, and risk management to SOP development, find out more about our services here.

Case Management / Safety database/ Literature

Risk Management Plan

Pharmacovigilance System Master File (PSMF)

PV Quality Management

Safety Reports

Eudravigilance

REGULATORY AFFAIRS

Whether it be a special regulatory project, intelligence, strategy or support with the essential life cycle management aspects, Regulink provides solutions that have delivered successful and cost-effective outcomes time after time. We are proud of the range and quality of services that we can provide, evidenced by the long term working partnerships we have established with our varied client list. Although not an exhaustive list, the main areas of our expertise and services are shown below:

PHARMACOVIGILANCE

Regulink provides pharmacovigilance services tailored to support your business needs. Our UK-based in-house QPPV has extensive experience from working as an EU and UK QPPV, with demonstrated leadership and management of large PV projects and teams of PV officers. We understand that all projects and clients are unique, so as with Regulatory Affairs, we offer a fully flexible service and work closely throughout to ensure your requirements are always met. The main expertise and services provided are shown below:

ABOUT US

Regulink was established by industry veterans, Stuart Reed and Sunil Singh, in 2014, following lengthy independent careers within industry and consultancy organisations. With recent changes to the consulting landscape, Regulink has rapidly grown to take on core partners with highly valuable and niche experience, as well as expanding its consulting partner network to be able to cater for its clients of all sizes. Regulink now offers consulting and other services in UK, Europe, US and Australia, supported by local expertise, and continues to grow, whilst always providing the flexible and scalable services that industry needs.

OUR INSIGHTS

Read our expert’s thoughts on industry news and regulatory topics.

ABOUT US

INDUSTRY SECTORS

Regulink provides specialist consulting and support services in all areas of regulatory affairs, CMC, pharmacovigilance and project/ programme management to the life sciences industry. We have a broad team with relevant experience in the key sectors of this diverse industry.

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Risk Management Activities

Regulink’s PV specialist will help with your risk management and minimisation activities:

OTHER PHARMACOVIGILANCE SERVICES

Case Management / Safety database/ Literature

Risk Management Plan

Pharmacovigilance System Master File (PSMF)

PV Quality Management

Safety Reports

Eudravigilance

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REGULATORY AFFAIRS

PHARMACOVIGILANCE

ABOUT US

OUR INSIGHTS

ABOUT US

INDUSTRY SECTORS