Regulatory Optimisation Group (ROG)
Introduction/Overview/Mandate
The Regulatory Optimisation Group (ROG) is a cross-functional group, consisting of regulatory, business and IT experts from National Competent Authorities (NCA), the European Medicines Agency (EMA), the Coordination Group for Mutual Recognition and Decentralised Procedures for Human medicinal products (CMDh) and for veterinary medicinal products (CMDv), and industry (industry representatives to be nominated), both from human and veterinary domain.
Role of the ROG:
- Identify and evaluate concepts to improve the current operation of the regulatory network;
- Conduct impact assessments, both operationally and on a strategic level, to evaluate the potential effects of upcoming pharmaceutical draft legislation;
- Serves as a catalyst and opportunity to rethink how current processes and operations work across the EU Network;
- Complements Agile practices by achieving alignment cross - NCA and EMA areas of strategic input, bringing together experts from regulatory authorities, industry and other domains to facilitate collaboration and consensus building.
The ROG provides strategic input on relevant topics, including:
- To the Network Portfolio Advisory Group (NPAG), which in turn provides recommendations to the EMA Portfolio Board and Agile Value Streams;
- To the HMA/EMA tactical group on resourcing;
- To the Veterinary Strategy Focus Group;
- To CMDh/CMDv
Meeting frequency
The ROG meets every six to eight weeks.
Members and Representatives
The group consists of members within the Network and meets with Industry at certain timepoints.
Composition of the ROG group is as follows:
| Chair (NCA) | Runa Hauksdottir Hvannberg (IS) |
| Co-chair (EMA) | Zaide Frias (EMA) |
| Strategic advisor (NCA) | Aimad Torqui (NL) |
| 4 NCA members | Appointed by chairs |
| CMDh chair and vice-chair | Appointed by CMDh |
| CMDv chair and vice-chair | Appointed by CMDv |
| Value stream owners | Appointed by EMA |
| Subject matter experts | Appointed by EMA |
| 8 Industry standing representatives | Appointed by EU industry stakeholder organisations |
Business Community
The ROG NCAs Business representatives’ community aims to enhance collaboration and ensure alignment between Network Portfolio and NCA Roadmaps, addressing the absence of a unified platform for Network POs and SMEs. The purpose is to provide direct feedback to NPAG via ROG and support decision legitimacy for Network POs/SMEs.
Subgroups
The operational subgroups, such as PMS OG, are operational groups that can be triggered by any particular need arising from the regulatory ecosystem.
Contact
ROG Secretariat
Jana Ros Reynisdottir (IMA)
jana.r.reynisdottir@lyfjastofnun.is
Chairs
Runa Hauksdottir Hvannberg (IMA)
runa.h.hvannberg@lyfjastofnun.is
Zaide Frias (EMA)
zaide.frias@ema.europa.eu
Key documents
ROG Terms of Reference
Reactivation of ROG