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.

February 2020 issue

February 2020 Regulatory Rapporteur cover

Members-only articles 

  • The crucial role of CMOs in ATMP clinical and commercial product manufacture
  • Interview: Facilitating innovation in medicines
  • Meeting Report: European Medicines Agency workshop on the draft regulatory science strategy to 2025
  • Meeting Report: 2019 EBE Annual Conference on ATMPs - Developing ATMPs in a timely manner to meet patient needs

 

 

 

 

Issue archive

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

Search the archive (TOPRA Membership required for full archive access)

Archived issues earlier than 2015

If you require Regulatory Rapporteur articles or back issues published prior to 2015, please email publications@topra.org.

Articles for purchase

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Latest Issues
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Volume: 17
Issue: 02

In This Issue:
FOCUS: New approaches to medicines - utilising technology to develop innovative medicinal therapies

PLUS:
• How to get ahead in the devices job market
• New intelligence in regulatory operations
• India's engagement at the international level
Volume: 17
Issue: 01

In This Issue:
FOCUS: Repurposing drugs to target unmet needs

PLUS:
• Regulatory landscape: Looking ahead at what's in store for 2020
• CMC - Accelerated development: trials and tribulations
• Veterinary medicines - The international regulation of animal health products
Volume: 16
Issue: 12

In This Issue:
FOCUS: TOPRA Symposium 2019 - Europe at the forefront of healthcare regulation
Volume: 16
Issue: 11

In This Issue:
FOCUS: North America - A look at recent developments in the regulatory landscape across the region

PLUS
• Orphan drugs: The practicalities of using the EMA’s IRIS platform
• Medical devices: New device standards from the US FDA consensus list
• Letters: Nonclinical requirements for biotech-derived drugs
Volume: 16
Issue: 10

In This Issue:
FOCUS: Falsified Medicines Directive

PLUS
• Latin America - Positive changes in the regulatory environment
• CPD - European medical devices legislative framework
• Virtual trials - Understanding the basics and exploring the benefits
Volume: 09
Issue: 09

In This Issue:
FOCUS: Ireland's regulatory framework

PLUS
• Interview: David Mukanga from the Gates Foundation, Africa
• Profile: FDA's Ned Sharpless
Volume: 16
Issue: 07

In This Issue:
FOCUS
Paediatric Medicines: How to address unmet needs in this vulnerable patient population

PLUS
• Drug-device combinations: major changes head
• DIA Europe 2019 - key topics for the future
• New EU VMR - impact on veterinary medicines
Volume: 16
Issue: 06

In This Issue:

FOCUS: Clinical trials

PLUS
• Malta's mutually beneficial interactions with EU partners
• Updates from the VMD for the veterinary sector
• Cultural diversity - tackling subliminal workplace bias
Volume: 16
Issue: 05

In This Issue:


FOCUS: EU Device and IVD Legislation

PLUS
• Producing periodic benefit–risk evaluation reports
• New FDA strategy for interaction with biosimilars sponsors
• Medicines development in Turkey: a regulator’s view
Volume: 16
Issue: 04

In This Issue:


FOCUS: Exploring New Health Technologies

PLUS
• How the European Commission supports HTA collaboration
• Insights on the unique regulatory requirements for GMOs
Volume: 16
Issue: 03

In This Issue:


FOCUS: Antimicrobial resistance: What the profession is doing to combat one of the greatest health threats today

PLUS
• The impact of the EU MDR on combination products
• Small markets - challenges for the regulator
• How to frame an EU-compliant pharmacovigilance system
Volume: 16
Issue: 02

In This Issue:


FOCUS: ATMPs

PLUS
• CMC section of an EU IMPD - advice for US sponsors
Volume: 16
Issue: 01

In This Issue:


FOCUS: Challenging access markets

PLUS
• EMA's relocation to the Netherlands
• Brexit's impact on the devices sector
Volume: 15
Issue: 12

In This Issue:


FOCUS - 2018 Annual Symposium
WITH REPORTS ON
Human medicines
Medical devices
Veterinary medicines

Please login to view member only articles. Non-members may download the public articles.
Volume: 15
Issue: 11

In This Issue:


FOCUS - North America
PLUS
Regulation of veterinary homeopathy products
A five-year review of MAH compliance in the EU
Devices standards update

Please login to view member only articles. Non-members may download the public articles.
Volume: 15
Issue: 10

In This Issue:


FOCUS - Brexit and its implications
PLUS
Demystifying medical devices
Harmonisation of SmPCs for veterinary products

Please login to view member only articles. Non-members may download the public articles.
Volume: 15
Issue: 09

In This Issue:


FOCUS - Chemistry, Manufacturing and Controls
Plus
Professional development in regulatory affairs
Paediatric studies: advancing child health?

Please login to view member only articles. Non-members may download the public articles.
Volume: 15
Issue: 07

In This Issue:


FOCUS - Regulatory affairs careers
PLUS
How to commercialise advanced therapies in the EU
GDPR: reducing data breaches and litigation

Please login to view member only articles. Non-members may download the public articles.
Volume: 15
Issue: 06

In This Issue:


FOCUS - Real world data/real world evidence
PLUS
Drugs for neglected diseases – a collaborative initiative
Meeting report: Innovative medicines and early access

Please login to view member only articles. Non-members may download the public articles.
Volume: 15
Issue: 05

In This Issue:


FOCUS - Veterinary medicines
PLUS
Medical device regulation: Why further guidance is needed

Please login to view member only articles. Non-members may download the public articles.

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