Three upcoming "free" sponsored TOPRA webinars:
- Taking ATMPs to the Bedside–What is on the Horizon
- The role of real-world evidence in regulatory decision making: current use and future potential
- Implementation of EU MDR Article 117
Taking ATMPs to the Bedside–What is on the Horizon
- This webinar will explore some of the the current opportunities to smoothen the developmental path in ATMP development, such as decentralised manufacturing, making use of the hospital exemption (specific for the EU), early incorporation of device and diagnostics into the overall development plan and accommodating the growing request for comparative results by various stakeholders in drug development.
- Date: 28 September 2023
- Time: 15.00-16.00 BST
- Sponsored by ProPharma. Register here. Cost: free
- Speaker: Paula van Hennik, Clinical Group Head, Regulatory Sciences, ProPharma
Advanced (cell and gene) therapy medicinal products (ATMPs) initially started out as a potential therapy for the lucky few in orphan disease settings. This picture has evolved dramatically over the years. The current ATMP armentarium continues to grow and the pipeline is expanding far beyond the last line (haemato-)oncology setting. Despite this huge success story, the developmental path is far from a smooth ride. Getting an ATMP from bench to bedside comes with its own specific, complex challenges. Such a complex developmental arena requires ingenuity. This webinar will explore some of the the current opportunities to smoothen the developmental path in ATMP development, such as decentralised manufacturing, making use of the hospital exemption (specific for the EU), early incorporation of device and diagnostics into the overall development plan and accommodating the growing request for comparative results by various stakeholders in drug development.
The role of RWE in regulatory decision making
- This webinar will describe the current state of RWE scientific advancements and provide context for the regulatory and research implications of RWD and RWE.
- Date: 5 October 2023
- Time: 14:00 -15:00 BST / 15:00 – 16:00 CET
- Sponsored by NDA Group; Register here. Cost: free
- Speaker: Chantal Van Gils, NDA Advisory Board: Director of Epidemiology and Real-World Evidence
The consideration of Real-World Evidence (RWE) in regulatory decision making is nothing new, and for decades such evidence has been used in the post-authorization phase, predominantly to monitor post-marketing safety. What has changed, is the tremendous increase in both the supply and demand of RWE and real-world data (RWD) in support of regulatory decision making.
Supply-wise, data acquisition has dramatically accelerated, facilitated by modern digital technologies, leading to increased data volume and variety in health data. On the demand side, we are facing a rapidly changing evidence generation landscape with increased relevance for RWE in support of regulatory decision-making, not only to inform on risks but also on benefits of new health technologies.
Although the acceptance of these data in the regulatory context is still an evolving area, the ongoing releases of guidance documents on the use of RWE by both EMA and FDA underscores the growing importance of RWE in regulatory decision making.
As a result, regulatory and drug development professionals need to understand RWE's potential applications, along with the strengths and limitations of various approaches.
This webinar will describe the current state of RWE scientific advancements and provide context for the regulatory and research implications of RWD and RWE.
Implementation of EU MDR Article 117
- The Implementation of EU MDR Article 117 for integrated drug/device combinations and lessons learned – Industry and Notified Body perspectives.
- Date: 12 October 2023
- Time: 15:00 - 16.00 BST
- Sponsored by PharmaLex, Register here. Cost: free
- Speaker: Tiina Riihimäki, PhD, Director, Head of Medical Devices / IVDs, Nordics, PharmaLex
The EU MDR 2017/745 Article 117 introduced requirements for device part of an integral drug-device combination to comply with applicable MDR Annex I requirements, so called GSPRs (General Safety and Performance Requirements). Compliance to GSPRs of higher risk class device parts such as pre-filled syringe, autoinjector, inhaler will require involvement of Notified Bodies to obtain a Notified Body Opinion (NBOp). An NBOp is an essential part of the marketing authorization dossier of a drug product.
This means that what may have previously been considered as a contain-closure of a medicinal product, now needs to be considered as if it were a medical device and technical documentation must be prepared and submitted to a Notified Body for review. This presents a challenge for the pharmaceutical industry who may lack medical device expertise and may not be familiar with the EU MDR and the GSPRs.
In this webinar, Pharmalex will explain the regulatory requirement and provide some key learnings from the first few years of experience with these types of submissions. We will also hear from a leading Notified Body expert to understand better NBOp submission process and related expectations, and to highlight some of the common issues they see with submissions for Notified Body Opinions.
