Commentary

Commentary

05-Bengt-Podcast-artwork-Webvision

RegRapPodIn Conversation with Bengt Mattson

BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson

Careers-Podcast-artwork-Webvision

RegRapPodIn Conversation with Helena Corte-Real

BONUS EPISODE: In Conversation talking careers with Helena Corte-Real

RR-April-2024-Cover-original

Improving outcomes with data

Every day, we make decisions based on learning, regulations and guidelines. We are surrounded by many forms of information and data is the fundamental unit. The data and the inferences and decisions we make from it depend on the quality we receive. High-quality data is essential for accurate and reliable ...

RR-Mar-24-AsiaPac-Cover

Diverse and dynamic regulation in the Asia Pacific region

Starting in Australia, authors David Batka and Kate Burke look at the trends within its market for 2024. Two years ago, the Australian government and its regulatory agency, the Therapeutic Goods Administration (TGA), initiated an expert review of medicine and device regulations to bring about reforms for patient access, flexible ...

Cell-and-Gene-Therapy

Cell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession

Cell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession

AdobeStock_230441943

Developing a digital people strategy to harness the power of generative AI

Artificial intelligence is a science and applied technology that involves deductive processing and machine learning subsequently performing human-like tasks

AdobeStock_619300211

The increasing complexity of biological medicinal products

The world of biologics is shifting rapidly. In the more than 40 years since the introduction of the first biosynthetic human insulin in 1982, advances in scientific understanding and biotechnology have occurred at breakneck speed. This has resulted in the development of hugely novel products with the potential to give ...

2D4A8680

Advancing global
healthcare together

An annual fixture since 2004, TOPRA’s Symposium is Europe’s premier conference for regulatory affairs professionals with dedicated programme streams for human and veterinary medicines, medical devices and IVDs. This year the Symposium was in Lisbon, in partnership with Infarmed, Portugal’s national authority of medicines and health products

October-2023-Cover-Cows-02

Veterinary medicines: the challenges of new regulation

The October 2023 edition of TOPRA’s journal – Regulatory Rapporteur – focuses on topics and developments specific for veterinary medicines:

AdobeStock_585476774

The worldwide web of regulation

In this issue, we focus on the pharmaceutical supply chain and the interaction of this function with regulatory. The supply chain team are the link between the manufacturer and the customer, and they are impacted by the complexity of regulations across different global markets and work with regulatory colleagues to ...

AdobeStock_81252287

Equal access to medicines:
finding the balance

This edition of TOPRA’s Regulatory Rapporteur journal explores some of the challenges faced by regulatory professionals around the world; from the African regulatory ecosystems, to health technology assessment (HTA), and the ongoing impact of the EU Medical Devices Regulation (MDR) on clinical studies and data.

RR-JUNE-2023-COVER

Clinical trials:
Ethical, ecological
and economic change

In the pursuit of global – or even regional – standards in requirements to support medical product development; is industry keeping up? Can regulations and guidelines keep up with the pace of change?

AdobeStock_512744306_edited

Mind the gap:
Innovation vs
regulation of ATMPs

Technology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.

Latin America

The region walking the regulatory walk

Latin America (LATAM) is a large market with considerable promise for pharmaceutical growth, with a total potential patient population of more than 600 million people. The landscape in Latin America is changing quickly with demand growing as populations age and chronic diseases become commonplace.

Legalise-Cannabis

Part 4. UK routes to registration for medicinal cannabis

Final article in a four part series considering uses of medicinal cannabis

Cannabis&Doctors

Part 3. The medical applications of cannabis

Third in a four part series considering uses of medicinal cannabis

Cannabis&Law

Part 2. Regulatory background of medicinal cannabis in EU and UK

Second in a four part series considering uses of medicinal cannabis

AdobeStock_434233415

Part 1. An introduction
to medicinal cannabis

The first in a four part series considering uses of medicinal cannabis

Setting the right standards

Setting the right standards

The theme of this issue is global standards but – as the contents reflect – the process by which documents and data become ‘standardised’ is anything but homogeneous or harmonised.

The need for robust quality management

The need for robust quality management

It is a simple fact that the establishment of a robust quality management system (QMS) can both drive – as well as facilitate – regulatory compliance across all layers of business and operations in the pharma and MedTech industries. However, there is no doubt that the mention of QMS can ...

Science is more than you think

‘Science is more than
a body of knowledge’

How the Regulatory Rapporteur’s online platform will provide its online journal experience

Picture12

Patient evidence and engagement

Don’t we in Life Sciences excel at generating abbreviations and acronyms? For example, do you know your COA from your PED or PPI? Or PEE from PRO? If you don’t, an explanation will be forthcoming in this edition of the Regulatory Rapporteur.

5M4A1970_TOPRA Symposium 2022_Day 2_20221018

Waltzing into change in Vienna:
The regulatory future comes into focus

It is the most wonderful time of the year – yes, that is Symposium issue time – and the Regulatory Rapporteur editorial team never want to disappoint! The TOPRA Symposium is one of the major annual events for those working in regulatory affairs, and the 2022 Symposium – hosted in ...

AdobeStock_242940510

Adapting, transforming and innovating

For the past two years, global regulatory authorities have faced an un usual set of circumstances – navigating a pandemic while simultaneously producing more advice, guidance and regulations than ever be fore. The COVID-19 pandemic forced authorities to introduce new processes very quickly, and work closely with other authorities, public ...

AdobeStock_366012972 (1)

Great expectations for medical technologies

Few would dispute that the medical technology regulatory system continues to creak under the strain imposed by the regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746). At the time of going to print, the Medical Device Coordination Group (MDCG) issued proposed ...

AdobeStock_507191894-WIDE

Regulatory operations: Evolution and revolution

‘Operations’ does not quite do justice to the critical role that these individuals play in the global team

AdobeStock_415521464

A new era of digital and data-driven innovations

Such significant advances in information management and technology are providing us with sophisticated tools and new ways of working

AdobeStock_210673709-min

How regulators are navigating the evolving pharmacovigilance landscape

In the area of regulatory affairs and pharmacovigilance (PV), we are constantly confronted with new laws, guidelines and other regulations

AdobeStock_226352071

CMC acceleration is driven by a scientific revolution

The role of CMC technical and regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals

tree

The future of pharmaceuticals is green

The healthcare sector is not immune from societal concerns about the environment and will have to go green over the next few years

brexit

The UK and Brexit – innovation and optimism in uncertain times

Although there is still alignment with the EU, the regulatory strategy for new submissions and variations has changed and we must adapt to such changes. No doubt further changes are on the way, which we must be ready for again.

drug development

Regulatory support for drug development – maximising options for timely patient access

As medicinal innovation evolves and becomes more complex, there is a need for agencies to support this innovation by establishing additional expedited pathway routes to improve drug development and its evaluation

covid

What does 2022 have in store for clinical trials?

Although the pandemic is not over yet, as we move forward, we must embrace these advances and not return to ‘business as usual’ despite the challenges such ways of working entail

AdobeStock_177887984

A regulatory revolution – driven by data

On occasions it felt like time was standing still in 2021, with further restrictions and lockdowns taking us out of our ‘normal’ routines and nothing much seeming to happen day-to-day, yet it still feels like the year has come around quickly to the Annual Symposium issue!