The Sales & Marketing Effectiveness in Chemicals Forum will bring together industry leaders as well as experts responsible and deeply involved in sales and marketing strategies.
Let your knowledge about biosimilars grow as fast as the market
Learn more about Biosimilars and its grow on Brazilian and Latin American market.
SÃO PAULO, October 14, 2015 – Over the past ten years, regulatory authorities worldwide have been focusing on developing guidelines for biosimilars and countries keep investing in their development.Brazil's Ministry of Health spends US$ 1 billion annually on biopharmaceutical products; 41% of the total budget allocated to medicines. iBut more than $60 billion worth of patents on biological products are set to expire before 2020, representing a major opportunity for the pharmaceutical industry. And it really is major. The global biosimilars market is estimated to be worth $2.29 billion in 2015 and the forecast for 2020 is that it will grow 22.1% annually. iiIt is crucial to find answers, so we, at Fleming, decided to gather top representatives from major companies and regulatory authorities across Latin America, the USA and the EU, as well as local and international organizations, for Biosimilars LATAMThe conference will take place on 18 – 19 November 2015 in São Paulo, Brazil, and the program is designed to be highly interactive and dynamic. The main focus areas concern the current state and outlook of the industry, mainly adoption, price and regulation of biosimilars as well as market reality and expectations of investors.Gabriela Cezar from Pfizer, Brazil, will present an overview of the growing Brazilian and Latin American market, followed by Renato Porto, from ANVISA, with the latest updates on local regulations, guidelines and regulatory strategies.The second day will mainly focus on clinical and non-clinical development and market strategies. Also, we mustn't forget about our unique case study about Novex, the first mAb biosimilar approved in Argentina.Biosimilars are ready for prime time. Are you? Source:i,ii http://globenewswire.com/news-release/2015/07/22/7...
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Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
Attendees will be introduced to comparability in biosimilar development, the analytical strategies of protein characterization of biosimilars, the structure of proteins, in vitro pharmacology and much more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Hassle-free air shipments with data loggers – 100% IATA compliant
Shipping temperature controlled pharmaceuticals is a complex business, with many variables and multiple supply chain partners involved. When shipments are sent with data loggers, they are subject to specific IATA and Dangerous Good Regulations to increase security of air cargo shipments. These regulations have become stricter year on year and reached a new level in 2017.
5 Changes in Signal Detection Management
The European Medicines Agency, regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. A safety signal is generally defined as information about a new or known Adverse Event that may have been caused by a medicine, where it is therefore necessary to conduct further investigation. Evaluation of safety signals plays a major role within pharmacovigilance. Therefore, it is vital for regulatory authorities to know the latest updates detailing the risks and benefits of medicines. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.
Hazardous chemical waste and its impact on the environment
Discover more about production and threats that are caused by hazardous chemical waste.