There are unique considerations and nuances to the US Food and Drug Administration’s (FDA) pre-submission process for medical devices that companies need to consider. Known as the Q-submission (Q-sub) program, these pathways are a way of communicating with the regulator to obtain their feedback on particular topics that are germane to both the manufacturer and the regulator.
With pharmaceutical companies increasingly turning to outsourcing partners to support maintenance of marketed products, efficiency and reliability are imperative. Digitalization, in particular automation and AI, plays an integral role in streamlining processes and enhancing that outsourcing relationship.
The ICH-Q2 and ICH-Q14 together describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products. But what is it that defines the quality of a reportable value? The podcast explores how Bayesian statistics makes it possible to take an observation made during the validation of the analytical procedure and predict the uncertainty around any future result, and in so doing bridge the gaps that exist in the guidelines.
Brad Carlin is a statistical researcher, methodologist, consultant, and instructor. He currently serves as Senior Advisor for Data Science and Statistics at PharmaLex, an international pharmaceutical consulting firm. Prior to this, he spent 27 years on the faculty of the Division of Biostatistics at the University of Minnesota School of Public Health, serving as division head for 7 of those years.
Under the Medical Devices Regulation economic operators – that is manufacturers, the authorised representative, importers and distributors – all face new roles and obligations. While some of these responsibilities existed under the Medical Devices Directive, workload will be impacted. From requirements around Eudamed, to having a person responsible for regulatory compliance, to ensuring certain obligations are properly followed through to complaint management, the roles of all economic operators are affected and require careful consideration by companies with devices in the European market.
The next frontier in outsourcing is the management of established marketed products, which provide the opportunity to sustain revenue, keep maintenance costs low and ensure compliance of mature products.
A recent survey of senior pharmaceutical and biotech executives explores why IPD programs are becoming an increasingly important strategy to successfully bring a new drug to market.
To find out more, we speak with Frédéric Pailloux, Senior Director, Head of Integrated Product Development & Consulting, at PharmaLex.
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.
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.
The In Vitro Diagnostic Regulation (IVDR) means enormous upheaval for companies, as now up to 90% of products will need to be reviewed by a notified body before they are eligible for distribution in Europe under the IVDR. That’s a huge about-turn from the situation under the In Vitro Diagnostic Directive (IVDD), where approximately 80% of products were self-declared to the IVD Directive.
Listen to our expert, Terrance Thiel, in the latest PharmaLex podcast to learn more.
With the EU Medical Devices Regulation now in force, manufacturers need to ensure they understand and are ready to meet requirements, that they have reviewed how their products will be affected by reclassification, that they have engaged with the notified bodies and that they stay up to date with developments. Listen to the PharmaLex podcast – The Why, How, When and What of the Medical Devices Regulation with our expert Jean Boudaud.
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.