Papers

Moving beyond the existing regulatory paradigm

TOPRA Summit reportHow 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.

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