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.

July/August 2022 issue

Focus: Data governance - how industry is managing data in an era of advancing technology

Members-only articles

Focus articles: Data governance

  • Data governance as a strategic imperative for regulatory compliance
  • Digital and data-driven: A regulatory insight into information management at the EMA
  • Translating digitalisation trends into tangible solutions

Other articles:

  • One year experience on EU Medical Devices Regulation 2017/745 for single integral drug-device combination products
  • Antimicrobials in biopharmaceutical production
  • EU reclassification (Rx to OTC switch) regulatory framework - What are the key challenges and how might they be overcome?

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.

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Free articles

To read the current issue of Regulatory Rapporteur in its entirety, plus receive access to every issue going to back to 2015, join TOPRA today.

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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 July/August 2022
Regulatory Rapporteur July/August 2022
Volume: 19
Issue: 07

In This Issue:
Data governance: How industry is managing data in an era of advancing technology
Plus:
One year experience on EU MDR 2017/745 for single integral drug-device combination products
Antibiotics in
biopharmaceutical production
EU reclassification (Rx to OTC switch) regulatory framework
Read more »
Regulatory Rapporteur June 2022
Regulatory Rapporteur June 2022
Volume: 19
Issue: 06

In This Issue:
Pharmacovigilance legislation - Exploring the impact of pharmacovigilance legislation on human medicines
Plus:
Interview: Updates to quality legislation from the EMA
Article: Medical device standards update
Interview: Evolutions in patient healthcare at the MHRA
Article: Exploring Amgen's Project Orbis experience with sotorasib
Article: What can past decision-making data tell us about how the FDA will make future combination product categorisation decisions?
Read more »
Regulatory Rapporteur May 2022
Regulatory Rapporteur May 2022
Volume: 19
Issue: 05

In This Issue:
Chemistry, manufacturing and controls – Ensuring safe and effective pharmaceutical products
Plus:
Article: Procedure withdrawals in Europe: past trends, impact and communication recommendations
Article: Amgen’s experience of global expedited regulatory pathways in the development of sotorasib
Read more »
Regulatory Rapporteur April 2022
Regulatory Rapporteur April 2022
Volume: 19
Issue: 04

In This Issue:
Green Pharma - Exploring the green initiatives transforming the industry
Plus:
Interview: A review of paediatric development challenges, FDA collaboration and future trends
Article: Brexit: The regulatory landscape one year on
Meeting report: The DIA's accelerating CMC workshop
Read more »
Regulatory Rapporteur March 2022
Regulatory Rapporteur March 2022
Volume: 19
Issue: 03

In This Issue:
The UK post-Brexit: The future of the UK after Brexit
Plus:
• Article: Navigating the regulatory landscape for regenerative medicines in Japan
• Article: A review of Project Orbis: An initiative enabling faster patient access to cancer therapies
• Article: Hype over hemp as a veterinary feed additive?
Read more »
Regulatory Rapporteur February 2022
Regulatory Rapporteur February 2022
Volume: 19
Issue: 02

In This Issue:
Expedited pathways: How expedited pathways benefit patients and the industry
Plus:
• Article: Selection and justification of regulatory starting materials
• Interview: Building best regulatory practices in Brazil
• Meeting Report: The EMA’s Veterinary Big Data Stakeholder Forum (Part 2)
Read more »
Regulatory Rapporteur January 2022
Regulatory Rapporteur January 2022
Volume: 19
Issue: 01

In This Issue:
Advances in Clinical Trials: Innovative approaches to promoting diversity and patient access via technology

Plus:
• Article: A regulatory lens on an industry imperative: Diversity in clinical research
• Interview: Facilitating the use of information to improve global health
• Meeting Report: The EMA’s Veterinary Big Data Stakeholder Forum (Part 1)
Read more »
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 »