Papers

TOPRA Summit Report 2021

At this TOPRA Summit, developers and regulators gathered to discuss the flexibility, pragmatism and creativity deployed over the past 18 months with a view to considering whether it should now be possible to replicate this incredible feat for many other important medicines and what can be learned and translated into future regulation, while acknowledging those changes that simply cannot be adapted as the norm.

TOPRA Summit Report 2019

The 2019 TOPRA Summit was held on 23 May in London, UK, and examined two areas contributing significantly to the evolution of medicines regulation:

• Innovation in regulation – preparing for novel data and approaches that will challenge regulatory decision-making
• Evolution of patient engagement – considering how leaders of regulatory organisations should transform their team’s approach, and why.

Opening remarks were provided by Thomas Kühler, Head Global Regulatory Science and Policy EU/AMESA, Sanofi Aventis Research and Development, France. Dr Kühler highlighted that digital health is transforming the sector and providing opportunities to use non-traditional data sources to support product approvals. Hybrid approaches and data sets are being brought to regulators, raising questions on how they should be used in decision-making. Additionally, patient insights are now also routinely incorporated in the research and development of medicines. Regulatory agencies are interested in understanding how to use these insights to support regulatory decision-making, particularly in addressing unmet medical needs.

TOPRA Summit 2018 Briefing

TOPRA’s third annual Summit, held on 3 July 2018 in London, focused on how the regulatory profession can remain fit for purpose in a disrupted healthcare system. Participants discussed how digital technology will impact on all aspects of healthcare delivery; how regulatory professionals in industry and regulatory agencies are preparing to advise on the validation of devices used to gather data; and that regulation needs to evolve to ensure consistency and quality of data used in subsequent decision-making related to the benefits and risks of medicines and medical devices.

Promoting excellence in the regulatory affairs profession: a competency framework

In this article, we discuss the evolution of the Regulatory Affairs Competency Framework, and its significance. Our goal is to stimulate discussion about the current status of the profession and the knowledge, skills and abilities that regulatory professionals need today and in the future.

As innovation occurs, it is important that regulatory professionals stay relevant and have the necessary skills and competencies to make substantive contributions to their organisations. We believe that this framework is an important contribution towards this goal. In addition, it offers guidance on the role of the regulatory professional in the delivery of safe, high quality and accessible healthcare products for human and animal use to patients and consumers worldwide.

Regulatory convergence: a benefit to both patients and professionals

The second TOPRA Summit brought together an international group of regulatory professionals from diverse stakeholder groups to debate the importance of regulatory convergence in improving access to healthcare products for all patients. Questions asked included:

• Does the current regulatory approach help or hinder patient access to medicines?
• What are the real gains of increasingly complex regulatory requirements and do they increase costs to the degree that access is compromised?
• To what degree are relationships between industry, academia, regulators, patients, payers and healthcare providers affected by political changes and competition?
• How can future regulatory leaders acquire the tools necessary to keep up-to-date on new developments and maintain networks through which to offer input on new procedures, alliances and initiatives for sharing and collaboration?

Moving beyond the existing regulatory paradigm

How can the regulatory system adapt to encourage the development of innovative new medicines and technologies that deliver real value to patients in an increasingly cost-sensitive environment?

These were the challenges that an invited group of leading regulatory thought leaders, academics and patient advocates explored at the TOPRA Summit on 26 May 2016 in London.

Sophisticated new technologies and scientific tools offer faster, more effective drug development at a time when there are more promising new molecules in the pipeline than ever before. On the downside a challenging economic climate and increasing demand from an ageing population are focusing payers of healthcare on cost.

Patients and consumers are increasingly driving the healthcare agenda insisting that their voices are heard at all stages of medicines development so that endpoints, outcomes and quality of life reflect their needs.

Against this challenging backdrop, attendees debated issues across the medicines regulation spectrum agreeing that there is now an opportunity for some ‘blue-sky thinking’. The issues raised and how they could be tackled in order to re-design the drug approval process, facilitate collaboration, and improve communication and competences are outlined in our discussion paper.

Report of TOPRA's 'Bremain or Brexit?' meeting

On 3 May 2016, ahead of the referendum, TOPRA hosted a debate to consider the issues from a pharmaceutical and regulatory affairs perspective.

As a professional association, TOPRA did not take a position one way or another, but wanted to create an opportunity to debate an issue that is important to individual members and to the profession as a whole. Almost 40 TOPRA members attended the event, and there was a lively and wide-ranging discussion. Download the report, below.

Adaptive pathways: how the regulatory framework is evolving for innovative products

Adjusting the route to market is vital to support innovation and timely approvals for products that could cover unmet or high medical needs. However, what remains unclear is how to shape regulatory strategy to overcome the barriers and whether the evidence gathered for authorisation marries up with health technology assessment (HTA) strategy. Bottlenecks in bringing products onto the market and legislative frameworks at national level are of particular interest.

An interactive workshop held jointly by TOPRA and the DIA in June 2015 provided a forum to identify the challenges of adaptive pathways, including additional evidence generation and the barriers in global registration programmes. A Reflection Paper generated by this workshop highlights the themes identified, a summary of the discussions, and recommendations and key points is available below.

How can regulators and industry use social media?

In May 2015, TOPRA held a Roundtable discussion on the topic of social media in regulatory affairs, chaired by Sir Alasdair Breckenridge.

Download the notes on the discussion below.

Reflections on improving the EU system for marketing authorisation

In September 2014, TOPRA and DIA jointly ran a successful workshop to discuss the results of the Escher report 'Improving the EU system for marketing authorisation; Learning from regulatory practice'.

We then published a reflections paper to summarise the key messages from the workshop and stimulate discussion. Download the paper below.

TOPRA response to the proposals in Article 13 of the Proposed Regulation on Medical Devices

In January 2013 TOPRA issued a response to a proposed EU Regulation, supporting the concept that a regulatory professional acting for a device manufacturer should be qualified by relevant education and experience.