PharmaLex Talks6 Heinä 2023

20: Safety Reporting Requirements for Marketing in the EU

For US-based companies seeking to market their product in the EU, it can be a struggle to navigate a different market, and, in particular, to manage requirements from a safety reporting perspective. The podcast explores the challenges faced managing not only the European pharmacovigilance legislation but also dealing with each EU Member State, which can implement these requirements in their own way at the national level.

Bios:

Monica Buchberger is senior director of pharmacovigilance at PharmaLex, drawing on her many years in industry in pharmacovigilance and regulatory roles, including quality assurance systems and serving as the EU QPPV for Abbott Laboratories.

Stephen Sun is a physician by training who heads up the US pharmacovigilance team for global PharmaLex and is also the service area head for benefit-risk management.

Tämä jakso on lisätty Podme-palveluun avoimen RSS-syötteen kautta eikä se ole Podmen omaa tuotantoa. Siksi jakso saattaa sisältää mainontaa.

Jaksot(37)

5: Getting Ready for the IVDR

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 r...

11 Maalis 202214min

4: The Why, How, When and What of EU MDR Regulation

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 Qualit...

4 Helmi 202215min

3: Bayesian Statistics

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 h...

29 Marras 202132min

2: Challenges & Regulatory landscape for ATMPs

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.

15 Marras 202117min

1: Post Brexit landscape for the pharmaceutical industry

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 Ph...

6 Syys 202114min