Commentary
Commentary
RegRapPod − InConversation with Ivo Claassen
InConversation talks veterinary regulation with Ivo Claassen, Head of the Veterinary Medicines Division at the EMA
RegRapPod − InConversation with the UK ePI Task Force
InConversation talks electronic product information with Andrew Burgess and Michael Clarke
Sustainable pharmaceuticals
In this bumper July/August edition of Regulatory Rapporteur, we focus on sustainability and, in many aspects, we build upon our June theme of access to medicines. Sustainability in pharmaceuticals encompasses a broad range of practices aimed at minimising the environmental, social and economic impact of pharmaceutical production, distribution and consumption.
RegRapPod − June 2024
Vol.21 #6: In June 2024’s RegRapPod, host Alan Booth talks to Issue Editor Davina Stevenson about access to medicines
RegRapPod − In Conversation with Bengt Mattson
BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson
RegRapPod − In Conversation with Helena Corte-Real
BONUS EPISODE: In Conversation talking careers with Helena Corte-Real
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 ...
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 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
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
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 ...
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.
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:
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 ...
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.
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?
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.
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.
Part 4. UK routes to registration for medicinal cannabis
Final article in a four part series considering uses of medicinal cannabis
Part 3. The medical applications of cannabis
Third in a four part series considering uses of medicinal cannabis
Part 2. Regulatory background of medicinal cannabis in EU and UK
Second in a four part series considering uses of medicinal cannabis
Part 1. An introduction
to medicinal cannabis
The first in a four part series considering uses of medicinal cannabis
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
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
a body of knowledge’
How the Regulatory Rapporteur’s online platform will provide its online journal experience
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.
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 ...
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 ...
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 ...
Regulatory operations: Evolution and revolution
‘Operations’ does not quite do justice to the critical role that these individuals play in the global team
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
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
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
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
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.
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
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
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!
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