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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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Meeting ReportVM5: CVMP Guidelines Update:
Data protection (Article 40.5),
prescription status (Article.34) and benefit-riskThe secondary legislation and guidelines are as critical as Regulation 2019/6 itself in defining the future landscape for animal health in the EU. The concept and definitions of benefit-risk affect many different aspects of veterinary medicines regulation, as per the legislation.
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Meeting ReportThe DIA’s accelerating CMC workshop
The Drug Information Association’s (DIA) virtual accelerating chemistry, manufacturing, and controls (CMC) workshop, held between 28 to 30 September 2021, consisted of seven sessions. The workshop included presentations by representatives from industry, industry bodies, health authorities and regulatory governance bodies.
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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 2)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1–2 June 2021 as a virtual event with more than 500 participants globally connected. This is the second and final part of the meeting report; the first half was published in Volume 19 No. 1 of Regulatory Rapporteur.
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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 1)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1 and 2 June 2021 as a virtual event with over 500 participants globally connected.
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Meeting ReportMD5: Innovation in Drug-Device Combinations
The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…
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Meeting ReportIVD3: EU Implementation: Current State
The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…
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Meeting ReportMD4: Clinical investigations – Is coordinated CA assessment the future?
The first speaker was Amy Bennet, who highlighted that any coordinated clinical assessment requires sound data gathered from preclinical development, especially in class IIa, IIb and above devices.
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Meeting ReportMD3: Digitalisation: How to bring paradise into regulatory work
Martin Witte chaired and introduced this interesting session, which considered the digitalisation of medical device regulatory information –using technology to allow more effective interrogation and control of available data…
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Meeting ReportMD2: Global development strategy, which market should you go to first?
Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.
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Meeting ReportMD1: MDR implementation – is there a future for legacy devices?
The first speaker for this session was Derek Foit. He defined legacy devices per Article 120 MDR, provided examples of class I to class III devices including nanoparticles, nasal sprays as specific cases…
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Meeting ReportVM5: Post-authorisation under Regulation 2019/6
Dries Minne opened the final session of the Veterinary Medicines Symposium 2021, covering changes to post authorisation procedures under Regulation 2019/6.
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Meeting ReportVM4: Practical implementation of the Union Product Database
This session looked at one of the main elements of the practical implementation of Regulation 2019/6, which is the creation of a Union Product Database (UPD).
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Meeting ReportVM3: Regulation 2019/6 on antimicrobials; requirements and availability
During the session, the speakers presented an overview of the new and revised rules and guidance, explored the major hurdles for new AMs, and discussed how we can protect existing AMs on the market through measures such as harmonisation of summaries of product characteristics (SPC) and flexible dosing labels.