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.

December 2021 issue

Focus: TOPRA Annual Symposium 2021 - Revolution in Regulatory Affairs: How the pandemic is shaping regulatory science

Members-only articles

Focus articles: TOPRA Annual Symposium 2021

  • Pharmaceutical: Human Medicines Symposium
  • Medical Devices: Medical Devices/IVDs Symposium
  • Veterinary: Veterinary Medicines Symposium

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

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

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Latest Issues
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Regulatory Rapporteur December 2021
Regulatory Rapporteur December 2021
Volume: 18
Issue: 12

In This Issue:
Focus: TOPRA Annual Symposium 2021
- Revolution in Regulatory Affairs: How the pandemic is shaping regulatory science
Plus:
Pharmaceutical: Human Medicines Symposium
Medical Devices: Medical Devices/IVDs Symposium
Veterinary: Veterinary Medicines Symposium
Read more »
Regulatory Rapporteur November 2021
Regulatory Rapporteur November 2021
Volume: 18
Issue: 11

In This Issue:
Focus: US Regulatory Update- US emergency preparedness and response to the pandemic
Plus:
France implements major changes in its early access framework
Interview: Regulations of medicines in Denmark
Meeting Report: Stakeholders input into EU standards for data sharing
Read more »
Regulatory Rapporteur October 2021
Regulatory Rapporteur October 2021
Volume: 18
Issue: 10

In This Issue:
CPD; Digital health technologies:
EU/US frameworks

MEETING: EMA/AnimalhealthEurope
Info Day

INTERVIEW: Erik Hansson, former Deputy
Head of Unit, EC
Read more »
Regulatory Rapporteur September 2021
Regulatory Rapporteur September 2021
Volume: 18
Issue: 09

In This Issue:
MENA/Africa region: Delving into the regulatory framework of this diverse and growing region
Plus
Interview: Irena Storová – Director of SUKL, Czech Republic
Labelling: Insights on requirements in the Middle East and Africa
Decentralised clinical trials: Flexibilities adopted by regulators during COVID-19
Read more »
Regulatory Rapporteur July/August 2021
Regulatory Rapporteur July/August 2021
Volume: 18
Issue: 07

In This Issue:
Pain management
Regulatory considerations in pain treatments for humans and animals

Plus:
Storyboarding Meetings - Why they are useful for marketing applications
Meetings - EMA/HMA webinar on artificial intelligence
IDMP- Business benefits of implementing a new RIMS
Read more »
Regulatory Rapporteur June 2021
Regulatory Rapporteur June 2021
Volume: 18
Issue: 06

In This Issue:
Focus: Data Transparency - The challenges of disclosing adequate clinical trial information in a comprehensible format

Plus:
• ATMPs - How to obtain positive HTA recommendations
• ICH Q12 - Flexible management of post-approval changes
• Veterinary Medicines - EMA's veterinary data strategy explained
Read more »
Regulatory Rapporteur May 2021
Regulatory Rapporteur May 2021
Volume: 18
Issue: 05

In This Issue:
Focus: OTC/Consumer products - Why regulatory flexibilities are needed in an evolving
landscape for minor ailments and self-care

Plus:
• Rolling Reviews - How they effectively speed up the review process
• EU Veterinary Regulations - Impact on medicines availability and AMR
• Medical Technologies - Latest medical device/IVD standards update
Read more »
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 »