![[FROM LEFT] Claudia Popp, Olga Tkachenko and Marta Carnielli](https://ds982gbwnvyso.cloudfront.net/Pictures/274x183/4/4/1/441_5m4a4767_toprasymposium2022_day3_20221019_816643.jpg)
Latest
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Article‘Science is more than a body of knowledge.
It’s a way of thinking’*Following the launch of Regulatory Rapporteur on an online publishing platform earlier this year, our efforts are now focused on ensuring that we provide the best possible online journal experience for our members.
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Article
Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR
European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.
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Article
The application of patient preference information
Regulatory authorities are encouraging the submission of patient experience data, including patient preference information (PPI). We provide an overview of PPI and the use of PPI in the regulatory setting. Many PP health studies recognise the usefulness of PPI, however, challenges remain in defining how and when to incorporate it in the regulatory process. While the use of PPI in regulatory decisions has been limited, regulatory agencies, sponsors, and researchers continue to work together to develop guidelines to integrate PPI into approval decisions.
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Article
An integrated approach to collecting patient experience data: An industry perspective
Patient experience data (PED) are intended to provide information about patients’ experiences with a disease or condition. There is growing interest from multiple stakeholders, including pharmaceutical companies to collect PED to inform the development and commercialisation of new drugs. Present efforts to generate PED ofen result in disjointed, overlapping, or duplicated efforts within and between pharmaceutical companies.
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Letter to the editor
Quality: Partnering rather than policing?
My 25 years in industry started as a laboratory analyst before moving into Quality within mid-size Pharma biotech, and latterly focused on Phases 2 and 3. Fundamentally, clients (whether internal within a company or on an external consultancy basis) make contact when Regulators are imminently coming, when a new Executive ...
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Article
European regulatory fees – complexity, concerns and solutions for efficiency
Regulatory authorities charge fees for the services they provide related to marketing authorisations. This research aimed to understand the complexity and concerns around the fee calculation and payment process for EU procedures used for market approval of a drug and proposes potential solutions to improve efficiency.
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Interview
Every patient has a story to tell us
Dr Francesco Pignatti, Head of Oncology and Haematology at the EMA, discusses his career, his inspirations, and why it is important to involve patients in regulatory decisions.
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Case Study
Case study: The evolving regulatory environment
Reproduced from a webinar presentation, made in collaboration with TOPRA and Roche, given on December 15 by Caroline Kuhn, François Hebraud, and Vijay Reddi, of Roche.
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Article
TOPRA Annual Lecture:
Access to medicines beyond Europe:
The potential of relianceGreg Perry, Assistant Director General, discussed in this year’s annual lecture, learnings on the IFPMA and the impact of the COVID-19 pandemic on Africa. In particular, the importance of building a strong infrastructure within the continent, in relation to the establishment of the AMA.
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Article
HM1: A decade of innovative clinical trials: What have we learned and where are we going?
The session gave some insight on the Accelerating Clinical Trials in the EU (ACT EU) and the EMA Q&As on CCTs, a guidance regarding scientific aspects and the planning, set-up and submission for CTA applications, as well as conduct, reporting, analysis and interpretation of CCTs.
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Article
HM2: Are expedited programmes delivering on the promise to accelerate drug development and patient access?
Expedited programmes available in the US, Europe and UK all aim to streamline process and ensure early access of medicinal products to patients; however, they are not yet fully delivering on their promises.
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Article
HM3: Lessons learned and strategic priorities
The profession needs to adapt to the power of technology and the widespread dissemination of misinformation on social media is causing real-world harm.
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Article
HM4: Assessing the value of innovative therapies: trends, challenges and learnings
This session focused on the evolution of the European Medicines Agency (EMA) and The European Network for Health Technology Assessment (EUnetHTA) collaboration.
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Article
HM5: Digital health opportunities and advancements in healthcare
There are still many unanswered questions due to the silos between medicines and medical devices and there is a need for interdisciplinary cooperation – stakeholders with different skills – to optimally position Europe for innovation.
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Article
HM6: Innovation in regulatory science – The path from data to evidence and the promise to streamline the regulatory lifecycle
There is a global evolution in drug development and RWE policy, increasing contribution of RWD/RWE to clinical evidence generation.
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Article
HM7: Are patients the missing piece in the global drug development puzzle?
This session focused on patient engagement from different stakeholder perspectives.
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Article
HM8: The present and future of developing and commercialising cell and gene therapies in a global world
Gene therapies are highly innovative products which have been approved only for the treatment of rare diseases so far. Changes in manufacturing processes during development as well as difficulties in gathering large clinical data sets explain the common challenges encountered by gene therapy developers to demonstrate the benefit of their ATMP.
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Article
HM9: Strategy under uncertainty — Improving the odds of regulatory success
Following last year’s success, Daniela Drago, Carlos Langezaal and Fortunato Fred Senatore were back to conduct another interactive session. Attendees gathered into groups to discuss and propose regulatory strategies based on a number of scenarios, three of which will be described here.
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Meeting Report
IVD1: Current state –
and update on IVDR implementationThis session focused on the implementation of the IVDR which went live on 26 May 2022.
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Meeting Report
IVD2: Clinical Performance Evaluation Challenges
We are in a transition phase until EUDAMED is fully functional. Local Agency procedures must still be followed despite the IVDR go-live – this is administratively challenging.
![[FROM LEFT] Claudia Popp, Olga Tkachenko and Marta Carnielli](https://ds982gbwnvyso.cloudfront.net/Pictures/100x67/4/4/1/441_5m4a4767_toprasymposium2022_day3_20221019_816643.jpg)
