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SDEA Development

GVP I.C.1.5: “Contractual arrangements should be prepared with the aim of enabling compliance with the legal requirements by each party involved. When preparing contractual arrangements, the marketing authorisation holder should include sufficiently detailed descriptions of the delegated tasks, the related interactions and data exchange, together with, for example, agreed definitions, tools, assignments and timelines.

The contractual arrangements should also contain clear information on the practical management of pharmacovigilance as well as related processes, including those for the maintenance of pharmacovigilance databases.

Further, they should indicate which processes are in place for checking whether the agreed arrangements are being adhered to on an ongoing basis. In this respect, regular risk-based audits of the other organisation by the marketing authorisation holder or introduction of other methods of control and assessment are recommended”

Jonathan West is very experienced in the development of Safety Data Exchange Agreements (SDEAs), and has established SDEAs on a global basis with multiple partner companies.

SDEA writing services include:

1) Mapping all partner companies to determine where SDEAs should be in place

2) Providing SDEA templates relevant to each partner

3) Negotiating roles and responsibilities and timelines with each partner to ensure adherence to regulatory requirements

4) Maintaining KPI and compliance metrics for each partner

5) Running periodic meetings with the partners

6) Auditing

Please call +44 (0)1363 775981, email info@phvservices.com or click to discuss your requirements.