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 quality management system.
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.
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.
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.
