GET THE APP

Analytical strategies for the marketing approval in highly regulated markets
..

Journal of Bioanalysis & Biomedicine

ISSN: 1948-593X

Open Access

Analytical strategies for the marketing approval in highly regulated markets


4th International Conference and Exhibition on Biologics & Biosimilars

October 26-28, 2015 Baltimore, USA

Robert E Zoubek

Granzer Regulatory Consulting & Services, Germany

Posters-Accepted Abstracts: J Bioanal Biomed

Abstract :

With increasing experience with Biosimilars also the regulatorâ??s perspective has further evolved and is based on a fresh scientific principle. The author will provide the latest insights from interactions with regulators worldwide. He will present the current thinking regarding the analytical requirements of both, EMA and FDA. He will highlight the key requirements of todayâ??s Biosimilars development and exemplify different strategies to obtain marketing approval.

Biography :

Email: zoubek@granzer.biz

Awards Nomination

50+ Million Readerbase

Journal Highlights

Google Scholar citation report
Citations: 2821

Journal of Bioanalysis & Biomedicine received 2821 citations as per Google Scholar report

Journal of Bioanalysis & Biomedicine peer review process verified at publons

Indexed In

 
arrow_upward arrow_upward