All Regulatory Rapporteur articles in December 2022
View all stories from this issue.
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EditorialWaltzing into change in Vienna:
The regulatory future comes into focusIt 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 ...
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JournalTOPRA 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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JournalHM1: 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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JournalHM2: 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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JournalHM3: 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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JournalHM4: 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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JournalHM5: 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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JournalHM6: 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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JournalHM7: 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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JournalHM8: 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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JournalHM9: 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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![[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)
Meeting ReportIVD1: 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 ReportIVD2: 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.
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Meeting ReportIVD3: IVDR for small companies and start-ups
When developing novel products, small companies and start-ups must understand the regulatory pathways to market. NBs are providing support to industry in its transition to the EU Medical Device Regulation, but NBs are in high demand.
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Meeting ReportMD2: How to approach Artificial Intelligence
and Cybersecurity now and in the futureCybersecurity is important for medical devices – those designed before the era of cybersecurity are most vulnerable to malware attacks and industry are searching for solutions.
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![[FROM LEFT] Alwin van den Broek and Walter van Der Weegan](https://ds982gbwnvyso.cloudfront.net/Pictures/100x67/4/3/0/430_5m4a4635_toprasymposium2022_day3_20221019_77249.jpg)
Meeting ReportMD3: Clinical investigation from
a virtual setting perspectiveThere is a variety of devices currently used to collect PROs and the data gathered in relation to orthopaedic surgery. The forthcoming AI, cyber resilience, data governance, and digital market acts are proposed as the regulatory landscape of the future.
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Meeting ReportMD4: Challenges and opportunities for
small companies and start-upsWhen developing novel products, small companies and start-ups must understand the regulatory pathways to market. NBs are providing support to industry in its transition to the EU Medical Device Regulation, but NBs are in high demand.
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Meeting ReportMD5: How to maintain your medical device
on the market and fulfil ongoing obligations
in the post-launch phaseEUDAMED is an integral part of the MDR and the actors, UDI and certificate modules are now live. The full effect of EUDAMED will not be realised until it is fully functional – all actors should accelerate their preparation for EUDAMED and upload information as soon as modules go live.
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JournalVM1: Availability and Innovation - under a new VMP legislation
The requirements for quality data for LM products have increased under the new Regulation. It is difficult to determine which regulatory framework is most appropriate for novel ATMs.
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JournalVM2: Novel therapies in animal health – Balancing guidance versus gaining flexibility
The new EU Veterinary Medicines Regulation contains specific provision for novel therapies. Established methodologies for demonstrating quality, safety and efficacy of veterinary medicinal products often cannot be applied to novel therapies.