PharmaLex Talks

Introduction: 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...

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 year...

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 ob...

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. It also looks at key considerations for managing the oversight of these products, in particular with regards to a qua...

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.

IVDR Brings Huge Change to Manufacturers Distributing Products in Europe 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 approxi...

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 Mas...

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...

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 foresee...