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.

November 2019 issue

November 2019 Regulatory Rapporteur

Members-only articles 

  • Interview with AbbVie's Khyati Roberts: Outlook on healthcare affairs in the US
  • From unstructured to structured data – US nonclinical data standards
  • Managing an FDA new drug application from outside the US: a case study
  • A regulatory landscape shift of in silico clinical trials
  • Biopharmaceutical regulatory intelligence programmes: current status and trends
  • The European Medicines Agency's IRIS platform: one year on
  • Medical device standards update
 

Issue archive

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

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Archived issues earlier than 2015

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Latest Issues
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Regulatory Rapporteur November 2019
Regulatory Rapporteur November 2019
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
Read more »
Regulatory Rapporteur October 2019
Regulatory Rapporteur October 2019
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
Read more »
Regulatory Rapporteur September 2019
Regulatory Rapporteur September 2019
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
Read more »
Regulatory Rapporteur July/August 2019
Regulatory Rapporteur July/August 2019
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
Read more »
Regulatory Rapporteur June 2019
Regulatory Rapporteur June 2019
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
Read more »
Regulatory Rapporteur May 2019
Regulatory Rapporteur May 2019
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
Read more »
Regulatory Rapporteur April 2019
Regulatory Rapporteur April 2019
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
Read more »
Regulatory Rapporteur March 2019
Regulatory Rapporteur March 2019
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
Read more »
Regulatory Rapporteur February 2019
Regulatory Rapporteur February 2019
Volume: 16
Issue: 02

In This Issue:


FOCUS: ATMPs

PLUS
• CMC section of an EU IMPD - advice for US sponsors
Read more »
Regulatory Rapporteur January 2019
Regulatory Rapporteur January 2019
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
Read more »
Regulatory Rapporteur December 2018
Regulatory Rapporteur December 2018
Volume: 15
Issue: 12

In This Issue:


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

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Regulatory Rapporteur November 2018
Regulatory Rapporteur November 2018
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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Read more »
Regulatory Rapporteur October 2018
Regulatory Rapporteur October 2018
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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Read more »
Regulatory Rapporteur September 2018
Regulatory Rapporteur September 2018
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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Regulatory Rapporteur July/August 2018
Regulatory Rapporteur July/August 2018
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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Regulatory Rapporteur June 2018
Regulatory Rapporteur June 2018
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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Regulatory Rapporteur May 2018
Regulatory Rapporteur May 2018
Volume: 15
Issue: 05

In This Issue:


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

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Regulatory Rapporteur April 2018
Regulatory Rapporteur April 2018
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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Read more »
Regulatory Rapporteur March 2018
Regulatory Rapporteur March 2018
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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Read more »
Regulatory Rapporteur February 2018
Regulatory Rapporteur February 2018
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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Read more »

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