All Journal articles – Page 6
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
JournalHM7: Are patients the missing piece in the global drug development puzzle?
This session focused on patient engagement from different stakeholder perspectives.
-
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.
-
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.
-
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.
-
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.
-
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.
-
JournalVM4: Regulatory update and perspectives: Variations, packaging and labelling, pharmacovigilance
Industry is navigating through complex new rules and opportunities for variations and will require continued cooperation. The year 2023 is expected to show the benefits of the revised pharmacovigilance procedures in practice.
-
-
JournalMedical Device Standards Update
This edition of our regular column updates the progress of applicable standards to September 2022.
-
![AdobeStock_424041822 (1) [Converted]](https://ds982gbwnvyso.cloudfront.net/Pictures/100x67/3/4/5/345_adobestock_4240418221converted_918379.png)
JournalBreakthrough therapy designation: From serious diseases to opioid crisis prevention
Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...
-
JournalThe worldwide acceptance of non-legalised eCPPs
The transition from paper-based format to electronic Certificates of Pharmaceutical Product (eCPPs) has seen an increased uptake as a result of the operational limitations associated with the COVID-19 pandemic. While issuing regulatory agencies (RA), such the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) now offer ...
-
-
JournalThe power of collaboration
Katherine Tyner, FDA Liaison to the EMA, Office of Global Policy and Strategy, FDA, discusses her position as a primary point of contact between the world’s two most important Agencies, and the goals they share for the future of public health.
-
JournalUS FDA CDER and CBER guidance of interest
The US Food and Drug Administration (FDA) has been steadily increasing the number of guidance documents produced on a yearly basis over the past decade. However, even with this increased pace, there are numerous topics that industry is looking to the FDA for clarity, especially newer topics like gene therapy, ...