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.

April 2021 issue

Focus: Regulatory Intelligence

Members-only articles

Focus articles: Nonclinical studies

  • Supercharging drug discovery, research, and development
  • Paediatric drug development – the 3Rs and the evolution of juvenile animal studies
  • GLP vs non-GLP – regulatory expectations for nonclinical studies
  • US FDA requirements for nonclinical data

Other articles:

  • Artificial intelligence: What can 70,000 research papers tell us about how AI is impacting life sciences?
  • Interview: EMA's Alexis Nolte - Regulating through the choppy waters of a pandemic

Use the issue archive below to download the complete issue as a PDF or to access individual articles or complete issues going back to 2015.

Note: To access members-only content, you must be logged in to the site with your TOPRA Member account.

 

Free articles

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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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Regulatory Rapporteur April 2021
Regulatory Rapporteur April 2021
Volume: 18
Issue: 04

In This Issue:
Focus: Nonclinical studies - Laying the foundations for the development of new pharmaceutical compounds

Plus:
• Interview - Alex Nolte, head of EMA's human medicines division
• Artificial intelligence - Discovering solutions for better patient outcomes
• The 3Rs - Designing studies with juvenile animals
Read more »
Regulatory Rapporteur March 2021
Regulatory Rapporteur March 2021
Volume: 18
Issue: 03

In This Issue:
Focus: Regulatory Intelligence - Processing targeted information and data to generate a meaningful output

Plus:
• CMC: Impurity management in clinical studies
• INTERVIEW: Celebrating 30 years of ICH harmonisation efforts
• MEETING REPORT: Advancing CMC workshop: Global challenges
Read more »
Regulatory Rapporteur February 2021
Regulatory Rapporteur February 2021
Volume: 18
Issue: 02

In This Issue:
Focus: Asia Pacific - Examining regulatory issues in the far east continent and beyond
Plus:
• COSMETIC PRODUCTS: Navigating the rules on advertising claims
• ATMPs: Regulation of advanced therapies in the US
• IDMP AND THE SPOR INITIATIVE: What these are and why they are important
Read more »
Regulatory Rapporteur January 2021
Regulatory Rapporteur January 2021
Volume: 18
Issue: 01

In This Issue:
FOCUS: Veterinary medicines
Plus:
COVID-19 VACCINE: Using challenge studies to speed time to market | ATMPs: DIA-EUCOPE workshop on advanced therapies | DIA GLOBAL 2020: Global Annual Meeting and Virtual Conference
Read more »
Regulatory Rapporteur December 2020
Regulatory Rapporteur December 2020
Volume: 17
Issue: 12

In This Issue:
Focus: TOPRA Annual Symposium 2020
- The evolving world or regulatory affairs: innovate regulation or regulate innovation?
Read more »
Regulatory Rapporteur November 2020
Regulatory Rapporteur November 2020
Volume: 17
Issue: 11

In This Issue:
Focus: A look across the Atlantic
- Exploring topics ranging from new FDA guidances and regulations to Health Canada’s current framework

Plus:
• Regulatory intelligence: Automated approach to text mining and curation
• Early access schemes: Overview of programmes across EU member states
• Medical devices/IVDs: Latest standards update
Read more »
Regulatory Rapporteur October 2020
Regulatory Rapporteur October 2020
Volume: 17
Issue: 10

In This Issue:
Focus: Medical technologies
Plus:
• CPD - Insights on expedited drug development pathways
• ATMPs - An overview of advanced therapy regulation in the EU
• Strategic planning - How to do regulatory affairs strategic planning well
Read more »
Regulatory Rapporteur September 2020
Regulatory Rapporteur September 2020
Volume: 17
Issue: 09

In This Issue:
Focus: Patient-focused development

Plus:
• Early access schemes: A heterogenous landscape with room for harmonisation
• ICH Q3E: Virtual symposium on extractables and leachables
• Patient information leaflets: Conveying complex information to patients
Read more »
Regulatory Rapporteur July-August 2020
Regulatory Rapporteur July-August 2020
Volume: 17
Issue: 07

In This Issue:
Focus: Looking after special populations

Plus:
• Virtual clinical trials: Ensuring continuity of research during a pandemic
• ICH Q12: Benefits and challenges with this enhanced framework
• Veterinary medicine: CMDv pilot part II harmonisation project
Read more »
Regulatory Rapporteur June 2020
Regulatory Rapporteur June 2020
Volume: 17
Issue: 06

In This Issue:
FOCUS: Biotechnology - Why and how regulators should keep pace with innovative biopharmaceutical advances

PLUS:
• Letter: A ‘SMArt’ new initiative for veterinary legislation
• Medical devices: Germany’s new device law, the EU MDR and COVID-19
• E-cigarettes: A look at the regulatory landscape in the US
Read more »
Regulatory Rapporteur May 2020
Regulatory Rapporteur May 2020
Volume: 17
Issue: 05

In This Issue:
FOCUS: Healthcare regulatory affairs in China

PLUS:
• Letters: Regulators united in fight against COVID-19
• Meeting report: Drug repurposing for rare diseases
• Devices: Latest medical device standards update
Read more »
Regulatory Rapporteur April 2020
Regulatory Rapporteur April 2020
Volume: 17
Issue: 04

In This Issue:
FOCUS: Real-world data - gathering data beyond clinical trials to obtain real-world evidence.

PLUS:
• Veterinary clinical trials: Overview and comparison between the EU and US
• Health apps: International initiatives to define requirements
• Mergers and acquisitions: Examining the benefits and challenges
Read more »
Regulatory Rapporteur March 2020
Regulatory Rapporteur March 2020
Volume: 17
Issue: 03

In This Issue:
FOCUS: Career and professional development strategies - Learn how to develop your skills and advance your career

PLUS:
• Meeting report: Drug-device combination
products workshop
• Interview: Animal and plant health scientific advice
• Artificial Intelligence: Potential impact on medical technology roles
Read more »
Regulatory Rapporteur February 2020
Regulatory Rapporteur February 2020
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
Read more »
Regulatory Rapporteur January 2020
Regulatory Rapporteur January 2020
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
Read more »
Regulatory Rapporteur December 2019
Regulatory Rapporteur December 2019
Volume: 16
Issue: 12

In This Issue:
FOCUS: TOPRA Symposium 2019 - Europe at the forefront of healthcare regulation
Read more »
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 »