EU efforts turn towards digital for 2019

By Karen Noonan, Vice President, Global Regulatory Policy

2018 was a busy and productive year for ACRO’s European Scientific & Regulatory Committee, which meets quarterly in London. While the Committee focused largely on the continuing implementation of the EU Clinical Trial Regulation, there were also opportunities to engage with regulators on other topics ranging from European regulatory strategy to Advanced Therapies to the urgent challenges of Brexit.

Meetings with EMA, HMA, MHRA, and HRA

In 2018, Committee members continued to engage with the EMA on the construction of the EU Portal and Database (as required by the EU Clinical Trial Regulation) via the EMA’s in-person stakeholder meetings (April and September) and via the in-person and remote User Acceptance Testing. In addition, ACRO subject-matter experts participated in EMA’s issue-specific workshops with industry and EMA’s strategic planning workshops with industry throughout the year – including:

  • EU Telematics Management Board and Industry Stakeholders Meeting (February and November)
  • 13th Industry platform meeting on the operation of EU pharmacovigilance (March)
  • EMA GCP IWG Workshop on electronic archiving of study data (May)
  • Recurring meetings on Brexit and the Centralised Procedure (March and September)
  • Committee for Advanced Therapies (CAT) meeting (September)
  • EMA Twelfth Pharmacovigilance Stakeholder Forum (September)
  • EMA Regulatory Science to 2025 Workshop (October)

Beyond EMA, ACRO member company experts also participated in stakeholder meetings with other agencies, including the HMA Clinical Trial Facilitation Group (CTFG) stakeholder meeting in Bonn (October). In the UK, ACRO attended the recurring UK HRA Phase 1 Advisory Group Meetings (March and October) and the MHRA Stakeholder Engagement Meeting (StEM) in May

Committee engagement with EFPIA and ABPI

In addition to vigorous engagement with regulators and policymakers, the Committee works to ensure regular communication with ACRO’s customer associations. The Committee reserves time during each of its quarterly meetings for a one-hour teleconference with EFPIA to enable information-sharing between the two associations and policy alignment whenever possible. ACRO also welcomed ABPI’s Deputy Chief Scientific Officer as an in-person guest at its June meeting.

Committee SME input to regulatory comments

The ACRO European Scientific & Regulatory Committee provided expert input into ACRO’s European regulatory comments in 2018, including comments to

  • EMA
  • European Commission
  • UK House of Commons

ACRO submitted 11 comments to European agencies in 2018. This work would not be possible without the contributions of experts from ACRO member companies. All of ACRO’s regulatory comments from 2018 can be found here on ACRO’s web site.

Looking Ahead to 2019

The EU portal and database, which is necessary for implementation of the Clinical Trial Regulation, will continue to be a priority in the year ahead, in addition to examining eConsent and eSignatures. ACRO intends to strengthen our relationship with EMA and play a positive role in key Agency priorities such as Antimicrobial Resistance. The Committee’s first meeting will be in London in March and we’re looking forward to an exciting slate of activities.

For more information on ACRO’s European advocacy, contact ACRO.

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