London, United Kingdom, May 15, 2019 --(PR.com
)-- This year’s event will address regulatory issues, alongside case reports of developing, forecasting and launching the next wave of biosimilars to ensure optimal uptake and successful commercialisation of these high-quality medicinal products.
Michel states, “I am delighted to cordially invite you to our 10th Biosimilars Conference taking place on the 25th and 26th September 2019 at the Copthorne Tara Hotel in London, UK.”
“After over a decade of successful experience with Biosimilars in Europe, the biosimilars industry is finally reaching a stage where key stakeholders better understand and accept biosimilars. This is reflected in the requirements for development, regulatory approval & post-marketing surveillance and an increased uptake of biosimilars across the globe.
“We are now entering a very exciting time, for over the next few years several originator patents are expiring, and we will see the next few waves of biosimilars enter the market. Will the biosimilar be a successful contender and spark a competitive environment or will the originator dominate? Have we done enough to convince the payer, prescriber and patient to switch?”
About Michel Mikhail:
Dr. Michel Mikhail has more than 30 years Pharmaceutical Industry experience and track record of achievement in R&D and International Regulatory Affairs in large multinational Research-based Pharmaceutical Companies, Biotech Companies as well as in the Generics industry. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr. Mikhail is a Global Expert in Biosimilars and International Regulatory Affairs Expert. He served as member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP).
The Biosimilars Conference two pre-conference, half-day workshops will commence on 24th September:
Workshop A: “Interchangeability in the USA: The US-FDA Regulatory Guideline” led by Michel Mikhail, International Expert Regulatory Affairs, Global Expert of Biosimilars.
· Workshop B: “Advancing Biosimilars Development and Uptake in MENA and GCC Regions.”
To download the 2-day conference agenda, half-day workshops and the expert speaker line-up, please visit the website at www.biosimilars-europe.com/pr2
Hear the experiences of prominent speakers and key opinion leaders and evaluate market access opportunities and commercialisation strategies with industry-thought experts at Biosimilars Conference 2019.
For those interested in attending, if you book your place by Friday 31st May you will save £300. Register online at www.biosimilars-europe.com/pr2
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SMi’s 10th Annual Biosimilars Conference
Conference: 25-26 September 2019
Workshops: 24 September 2019
Copthorne Tara Hotel, London, UK