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February 26, 2015
Regulatory requirements post clinical challenges – regulatory summit highlights
By: Kevin Julian

Our Accenture Accelerated R&D Services European regulatory team held a summit in London with pharma and biotech global regulatory operations leaders. The Operational Vision in Regulatory summit provided a facilitated forum for regulatory leaders to discuss the critical challenges facing the pharmaceutical industry, including the EU eSubmission Roadmap, Identification of Medicinal Products (IDMP) and the use of the electronic Common Technical Document (eCTD) New Major Version (NMV).

This year the summit welcomed keynoter Dr. Klaus Menges, PharmNet.Bund authorized representative at the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), an independent federal higher authority within the portfolio of the Federal Ministry of Health located in Bonn, Germany. Dr. Menges provided insightful Health Authority perspective to these challenges.

Highlights of the summit included active dialogue around the eSubmission Roadmap and the show of collective implementation concerns with eCTD NMV currently the least popular format for the Mutual Recognition Procedure (MRP) and one of three regulatory procedures available to applicants to gain multinational marketing authorization within the European Economic Area (EEA). Questions arose about the fundamental suitability of the format for this procedure, given the operational difficulties encountered, and there was discussion about whether MRP repeat use could be considered not a new application, so that the 2018 timeline would apply and more time could be given for resolution of practical issues.

Another topic of deliberation was Data Standard(s) Interconnectivity and IDMP. From the discussion, it appears that most Pharma Companies are at the very initial stages of identifying the impacts that IDMP will have on the organization.

A recent whitepaper, Navigating IDMP and the Healthcare Standards of the Future, written by ARDS European regulatory consultants and strategists touched on some of the challenges, risks and opportunities presented by IDMP:

  • Most companies will only hold the data in an unstructured format, on disparate/isolated systems, and under the guardianship of employees who may be oblivious to the requirement.

  • Expediting the transition may result in systems and processes that are inadequate, insecure, unreliable or not future-proofed.

  • Interconnecting people and information on such a grand scale, when done correctly, is a prime driver for greater efficiency, collaboration, insight and innovation.

The Accenture Accelerated R&D Services regulatory team will address these and other industry challenges as we work with industry partners, clients and peers. Our next step is to conduct additional summits in the Nordic countries, mainland Europe and in the United States.

Learn more about Accenture Accelerated R&D Services.

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