All Journal articles – Page 8
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JournalSuccessful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR
The new requirements in the MDR/IVDR will affect the QMS of medical device manufacturers, however, use of the ISO 13485 standard is a useful starting point in meeting many of these requirements. The use of a gap analysis, project implementation plan, and ISO 13485 provide an approach that will allow manufacturers to successfully transition from MDD/IVDD to MDR/IVDR.
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JournalConsiderations 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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JournalEuropean 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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JournalAn 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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JournalThe 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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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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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.
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JournalVM3: Antimicrobials; the new rules, their impact and consequences
The Veterinary Regulation 2019/6 established new provisions and obligations for antimicrobials in veterinary medicines. Work on implementing regulations and guidelines is ongoing to further specify their use and restrictions.