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 2020 issue

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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November 2020 issue cover

Members-only articles

  • Interview: Regulating healthcare products in Canada
  • Feature article: FDA issues guidance for 2017 final rule on penalties related to Clinicaltrials.gov database
  • Feature article: How the modernisation of FDA's New Drugs Regulatory Program enhances transparency and consistency
  • Meeting report: TOPRA/RAPS Workshop on Alignment of Global Combination Products 
  • Article: Early access in the EU: a heterogeneous landscape with room for harmonisation 
  • Article: Medical device standards update

Use the issue archive below to download the complete November 2020 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.

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

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 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 »
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 »

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