PharmaLex Talks

Classification and regulation around medical device software has become more complex, and in recent years most regulatory authorities have tightened the regulatory pathways. The podcast explores software differences and how these impact regulator classifications in various markets. It also looks at key considerations for managing the oversight of these products, in particular with regards to a quality management system.
Yervant Chijian, Director, Team Lead Medical Devices / IVD, Australia
Yervant provides expert technical consultancy for Medical Device regulatory compliance in major markets, ensuring efficient market access. He has spent the last 20+ years in the Medical Device field, including both manufacturing and product development. His expertise lies in Regulatory Strategic Planning, particularly in the United States, Europe, Canada, Australia, and New Zealand markets, and in Product Development and Design Controls, specifically in software and with active devices. Coupled with his experience in Manufacturing Processes, Quality Management Systems (ISO 13485 and MDSAP), and Product Lifecycle Management, he brings a comprehensive skill set to support clients navigate through the variety of regulatory pathways and requirements.

Some major changes have been outlined in the EU Annex 1 Revision. Listen to PharmaLex expert Patrick Nieuwenhuizen on how the industry can implement the new Annex 1.

Jean has extended experience in all phases of the product lifecycle, driving compliance from concept initiation through to commercialisation and post-market support.  He provides Regulatory and Quality Assurance expertise to a broad range of companies from start-ups to multinationals and supports projects involving various medical technologies. He is bilingual in French and English and holds a Masters’ Degree of Engineering (MEng.). 

This episode of PharmaLex Talks features Bruno Boulanger, Senior Director, Global Head Statistics and Data Science at PharmaLex and an award-wining author on Global Statistics and Data Science (link https://www.pharmalex.com/bookauthority-announce-the-winner-of-the-best-new-bayesian-statistics-books-best-new-biostatistics-books-and-best-statistics-ebooks-of-all-time/). 
Bruno´s visionary approach to statistics and his efforts to streamline predictive models and facilitate decision making in pharma are of considerable value for the industry. Clement Laloux, Specialist Statistics & Data Sciences at Pharmalex supports the discussion and shares his thoughts on the influence of prior usage, helping to predict recruitment in Clinical Trials.
This episode focuses around the smooth running of patient enrolment as a key determinant of success for Clinical Trials. The reality is that many Clinical Trials fail to complete on time due to delays in patient recruitment (more than 80% of the Trials do not reach recruitment targets on schedule, Huang et al., 2018). And despite efforts over multiple decades to identify and address barriers, recruitment challenges persist.
In this episode, we shed light on patient enrolment as a key determinant of success in clinical trials, challenges with delays in drug submission and even shortages in hospitals. We touch upon factors that can impact the decision making and facilitate the choice of procedures to adapt models of prediction, particularly Bayesian models.An important question is, how many additional centres should be opened in order to ensure completion within timelines? More practically, the proposed methodology is carried out under the Bayesian framework and aims at predicting the randomisation dates of future patients in the context of ongoing multicentre clinical trials.
If this topic is of interest to you, visit our webpage and check out our free webinar on the same topic:
https://go.pharmalex.com/pharmalex_webinar_bayesianapproachsupplychain_ondemand

Industry experts on ATMPs discuss the challenges and regulatory landscape with respect to the development of ATMPs, and what support and guidance is available from regulatory agencies.

Meeting the regulatory challenges of the post-Brexit pharma landscape
In the inaugural PharmaLex Talks podcast, host Elizabeth Hunt chats with Charley Maxwell, Director QMC / Senior Consultant at Pharmalex about the post-Brexit Pharma landscape. 
Their wide-ranging conversation covers many key issues including; the cost of Brexit to the Pharma industry so far, what have been, and what are foreseen to be the biggest challenges to come, how UK manufacturers are coping, the Northern Ireland Protocol, and more.