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.

May 2022 issue

Focus: Chemistry, manufacturing and controls - Ensuring safe and effective pharmaceutical products

Members-only articles

Focus articles: Chemistry, manufacturing and controls

  • Gene therapy products: regulatory challenges for industry
    A regulatory view on the change management process for medicinal products
  • Practical insights into the recent EU MDR framework
  • Regulatory Framework for Platform Technologies
  • CMC considerations for US biosimilars development

Other articles:

  • Procedure withdrawals in Europe: past trends, impact and communication recommendations
  • Amgen's experience of global expedited regulatory pathways in the development of sotorasib

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

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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.

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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 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 »
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 »