CIRS - The Centre for Innovation in Regulatory Science

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The Centre for Innovation in Regulatory Science (CIRS) is a neutral, independent organisation conducting novel research, convening international forums for healthcare stakeholders and providing science-based insights to advance global regulatory and HTA policies and enhance patient access to medicines.

CIRS: The Centre for Innovation in Regulatory Science

About Us
Global Development Programme
HTA and Market Access Programme
OpERA
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  - CIRS-BRAT Framework
  - UMBRA Initiative

Slide of the Month

October 2019 Slide of the Month

Regulatory review reliance models: What are the barriers and enablers to the successful use of these models for medicines?

Slide of the Month Archive >

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CIRS 2019 AGENDA

Download the CIRS 2019 Agenda

Where to meet us

2-6 November 2019 ISPOR, Copenhagen, Denmark

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Our most recent publications

Kuhler TC., Bujar M., McAuslane N., Liberti L. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016. BMJ Open 2019;9:e028677

2019 Project Report: Monitoring the adequacy of implementation and adherence to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines

CIRS R&D Briefing 73: Review of HTA outcomes and timelines in Australia, Canada and Europe 2014-2018

CIRS R&D Briefing 72: Trends in the Regulatory Landscape for the Approval of New Medicines in Asia

CIRS R&D Briefing 71: Trends in the Regulatory Landscape for the Approval of New Medicines in Latin America

R&D Briefing 70 New drug approvals in six major authorities 2009-2018: Focus on facilitated regulatory pathways and orphan status

Bujar M, McAuslane N, Walker S, Salek S. The reliability and relevance of a quality of decision- making instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for use during the lifecycle of medicines. Front Pharmacol. 2019;10:17. Published 2019 Jan 23. doi:10.3389/fphar.2019.00017

Keyter A, Banoo S, Salek S, Walker S. The South African regulatory system: past, present and future. Front Pharmacol. 2018; 9: published online 4 December.

Liberti L. The practical application of regulatory science: Impact on regulatory policy and practice. Reg Rapporteur. 2018; 15:3-5-9.

Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. The Turkish Medicines and Medical Devices Agency: Comparison of its registration process with Australia, Canada, Saudi Arabia, and Singapore. Front Pharmacol. 2018;9 DOI=10.3389/fphar.2018.

© CIRS: The Centre for Innovation in Regulatory Science 2019

Centre for Innovation in Regulatory Science