The “Biosimilars Training Course” conference is now available through ResearchAndMarkets.com, providing a crucial opportunity to anticipate and capitalize on the imminent growth within the biosimilars market. As numerous prominent biologics approach patent expiration in the coming years, the landscape of pharmaceuticals is poised for transformation, with biosimilars emerging as cost-effective alternatives.
In today’s pharmaceutical milieu, biosimilars represent a pivotal shift, offering viable options that adhere closely to their reference biologics. This seminar is designed to delve deeply into the intricate distinctions between biosimilars and their reference counterparts, navigating the complex regulatory pathways prevalent in both the EU and US markets.
Participants will acquire comprehensive insights into the specific dossier requirements essential for biotech products, contrasting them with pharmaceutical products. Strategic frameworks for effective biosimilar development will be explored, alongside critical biological considerations and the concept of totality in biological reviews, highlighting the distinctive aspects of biosimilars compared to conventional generics.
This course is tailored to empower attendees with the requisite expertise to navigate the evolving biosimilar landscape, covering essential topics such as global biotech and biosimilar product definitions, regulatory guidelines from EMA and FDA, and strategic considerations for global biosimilar development.
Certified with 12 CPD hours, this course is indispensable for professionals in pharmaceutical regulation, quality assurance, R&D, and related fields, including regulatory affairs professionals, clinical development managers, and legal and compliance officers.
Led by Andrew Willis, an esteemed consultant with extensive experience in global regulatory solutions and pharmaceutical development, this course promises practical insights drawn from a wealth of industry experience. His background includes pivotal roles in major regulatory projects across Europe and the US, contributing significantly to the advancement of biotech pharmaceuticals.
Participants can expect to gain invaluable knowledge and strategic perspectives, equipping them to navigate the challenges and capitalize on the opportunities presented by the burgeoning biosimilars market.
