Regulatory Rapporteur

Regulatory Rapporteur is our peer-reviewed journal, published 11 times per year and sent free to TOPRA members. Our CPD supplement is published four times a year and distributed with Regulatory Rapporteur

Non-members may access two articles per issue. Join TOPRA to get full access to our journal and CPD content.

Articles for purchase

For information about purchasing journals, articles or reprint licences, contact us at publications@topra.org.

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Read our Regulatory Rapporteur Author Guidelines

 

 

EU Centralised Procedure - October 2019

October 2019 CPD Supplement coverThis issue:

Fundamentals of the European devices regulatory framework


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EU Centralised Procedure - July/August 2019

July/August 2019 CPD SupplementThis issue:

Key steps and considerations of the EU centralised procedure


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Medical Devices - May 2019

This issue:

FDA regulatory pathways for medical devices


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Biosimilars - February 2019

This issue:

Regulatory complexities and challenges of biosimilars


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Paediatric Medicines - December 2018

December 2018 CPD SupplementThis issue:

Creating an integrated EU/US product development strategy for paediatric medicines


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US Regulatory Pathways - November 2018

TOPRA CPD SUPPLEMENT NOV 2018This issue:

Bringing new drugs to the market in the US: an overview


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Risk Management Plans - May 2018

This issue:

EU RMPs: Principles, preparation and challenges


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Veterinary Medicinal Products - April 2018

Oct 2017

This issue:

CMDv recommendations for reducing administrative burden


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Orphan Designation in the EU and US - October 2017

Oct 2017

This issue:

Securing and capitalising on orphan drug status


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CPD Health Technology Assessment - July/August 2017

Jul Aug 2017

This issue:

Health Technology Assessment: Assessing relative effectiveness


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Combination Products - April 2017

Dec 2016

This issue:
EU regulatory considerations


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Lifecycle Management - January 2017

Dec 2016

This issue:
EU and US variation requirements


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