Pharmacovigilance

Like the pharmaceutical industry, pharmacovigilance is entering a period of transition and it remains on the critical path for the approval of new medicinal products

Are you ready for the “biggest change to the regulation of human medicines in the region since 1995?”. The EU Pharmacovigilance regulation is fast approaching its implementation date of July 2012. The impact of the new legislation will be felt by stakeholders small and large and by Competent Authorities.

Examples of projects include:

  • Provide additional safeguards to public health
  • Strengthen post-authorisation regulation of medicines
  • Improve efficiency
  • Increase transparency

Is your company ready for the changes in the management of roles, processes and outputs in response to the new legislation?

Due to the critical nature of outputs from pharmacovigilance activities, the function itself is extremely process driven and highly regulated. It is essential that companies have the flexibility to evolve and keep up to date with ever-changing demands.

Kinapse’s team of PV experts have worked with some of the largest global pharmaceutical companies and Regulatory bodies in both consulting and outsourcing activities.

Why Kinapse for Pharmacovigilance?

Kinapse are working in collaboration with the Health Protection division within the European Medicines Agency to ensure that the existing adverse event data stored within EudraVigilance is coded accurately, free from duplicate reports and submitted by stakeholders to the standard of quality required by the EMA.

Our outsourcing team has been trained by the EMA to EMA processes in the assessment of ICSR quality and coding within AE reports and this allows us to understand how case processing should be undertaken.

The success of our projects have been due to our unique blended resourcing during set-up which provides our client with onsite PV experts to address issues, provide solutions and direct program leadership

Our outsourcing team is comprised of experienced pharmacovigilance experts who are dedicated to the Kinapse principles of quality, expertise and collaboration.

The expert project management within the PV outsourcing blended model allows us to quickly execute urgent tasks if required.

We provide the following services:

  • Case Processing – Full data entry from triage, duplicate detection, coding, narrative writing and medical review
  • Regulatory Reporting / Eudravigilance reporting – Paper submissions and e-submissions to regulatory authorities and third parties
  • Periodic Report Writing- Our team has experience in writing both PSURs and Annual Safety Reports. We are also prepared for the ICH requirement for Drug Safety Update Reports (DSURs)
  • Additionally both onshore and offshore resources are available for the generation of such documents as:
  • PV Training modules
  • Safety Data Exchange Agreements
  • QPPV expertise
  • Detailed Description of Pharmacovigilance System (soon to be replaced with the Pharmacovigilance master file)

Our team of PV experts know what the current PV legislation requires and we understand the impact of the forthcoming changes in PV legislation to Regulatory Bodies and Marketing Authorisation Holders.

Our PV consulting team are able to assess the impact of the forthcoming changes and advise accordingly on the resourcing requirements and process enhancements required. Additionally, we can add value to our life sciences clients from project start because we understand through Kinapse coverage of the pharma development and commercialisation value chain the needs of our clients’ internal stakeholders and because we derive synergy from our Outsourcing practice – we undertake the key processes so our advice is pragmatic, grounded in direct experience.

Our PV consultants also bring advanced project management skills and knowledge of pharmacovigilance. Areas in which our consultants can provide expertise:

  • Organisation design
  • Resourcing strategy including resource modelling and vendor management
  • Process enhancement
  • Performance management and productivity improvement
  • PV Quality management
  • Regulatory Inspection Planning and CAPA responses
  • PV System implementation

The following are Senior Members of our Pharmacovigilance team: