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.

September 2019 issue

Regulatory Rapporteur September 2019

Members-only articles 

  • Physician-scientist takes the lead at the US FDA
  • Regulatory Science Ireland and the regulatory dilemma for future innovative therapeutics
  • Interview with Kevin O'Donnell: The science of compliance
  • Ireland's ambitions and innovative for drug and research development
  • Switzerland: Recent legislative revisions impacting the pharmaceutical industry
  • EU cooperation on health technology assessment and beyond

Issue archive

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Latest Issues
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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

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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

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Volume: 15
Issue: 10

In This Issue:


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

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Volume: 15
Issue: 09

In This Issue:


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

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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

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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

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Volume: 15
Issue: 05

In This Issue:


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

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Volume: 15
Issue: 04

In This Issue:


FOCUS – Medical devices
PLUS
Navigating the devices field: Insights on the evolving requirements and innovations in medical devices
Clinical trial transparency within the pharmaceutical industry: Clear as mud?

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Volume: 15
Issue: 03

In This Issue:


FOCUS - Regulatory science
PLUS
The Paediatric Regulation: Ten years of experience reviewed
In conversation with the EU Heads of Medicines Agencies
The latest updates on medical device standards

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Volume: 15
Issue: 02

In This Issue:


FOCUS – Inspection readiness
PLUS
Overcoming obstacles in orphan drug development
Initiatives for regulatory convergence in Asian countries

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Volume: 15
Issue: 01

In This Issue:


FOCUS - Nonclinical studies
PLUS
An overview of differing switch processes in Europe
Aims for global veterinary regulatory alignment

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Volume: 14
Issue: 12

In This Issue:


2017 Annual Symposium
PLUS
Medical device standards update

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