Plain Pharma Consulting Ltd

By the end of 2020, all UK MAHs will require a UK QPPV.

The UK QPPV is responsible for ensuring that the MAH's pharmacovigilance system is compliant with the UK legislation.

Outsourcing the UK QPPV function can be a cost-effective solution to gaining the services of an experienced QPPV.

We can provide the services of an experienced UK QPPV to support and oversee the marketing authorisation holder’s pharmacovigilance system.

We can assist in the creation of new pharmacovigilance systems and the review and optimisation of existing pharmacovigilance systems.

This includes:

·       Creation and review of the pharmacovigilance quality management system

·       Writing and reviewing of individual SOPs and working practices

·       Gap analysis of an existing pharmacovigilance quality management system.

We can support your strategic and tactical audit plans by:

• GVP auditing of your company and your partners and vendors, on-site and remote

• Creation of risk assessment tools to determine who to audit and when

• Pre-inspection planning and inspection management

• Creation and implementation of post-audit and post-inspection CAPAs.

Management of contractual obligations with third parties, including preparation and maintenance of safety data exchange agreements.

We can author, review and implement SDEAs to ensure robust exchange of safety data between the marketing authorisation holder and its partners. 

We can support the development and maintenance of the PSMF, including its creation and review.

If a PSMF is already available, we can provide support for its update and maintenance, including the requirements for a UK PSMF from 2021.

Creation of the summary of the pharmacovigilance system.

We can support in the preparation and submission of aggregate safety reports (PSURs/PBRERs/DSURs) by:

• Developing and maintaining an aggregate report schedule

• Planning the preparation and review of individual reports

• Writing and reviewing aggregate reports

• Submission of aggregate reports

• Management of assessment reports and responding to assessment questions.

We can support literature monitoring activities for routine monitoring as well as for specific projects.

Weekly monitoring of global literature databases.

The design and validation of search strategies.

Weekly monitoring of the EMA’s MLM service.

Ad hoc literature searching for specific projects.

We can support risk management activities by:

• Developing and maintaining RMP schedule

• Planning the preparation and review of individual RMPs

• Writing, reviewing and updating RMPs

• Creation and implementation of additional risk minimisation measures and additional pharmacovigilance activities.

We can support signal management activities by:

• Creation of a proportionate signal management procedure

• Developing and maintaining a signal management schedule

• Conducting signal management reviews including the preparation of signal management reports.

Bespoke training can be provided on all aspects of clinical and post-marketing pharmacovigilance, including the training of non-pharmacovigilance personnel.

We can support medical information by:

·       Preparing FAQs based on information in the product labelling, marketing authorisation dossier, and from the clinical literature

·       Scheduling the review and revision of FAQs

·       Providing a medical information enquiry service for the marketing authorisation holder’s portfolio.

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We can review promotional materials in accordance with the requirements of the MHRA’s Blue Book, the PMCPA Code of Practice, and the PAGB Advertising Codes.

We can provide interim managers to cover gaps during the recruitment of senior managers or to manage ad hoc projects.