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PHARMACEUTICAL INDUSTRY EVENTS CALENDAR

TAT 2018 Ė Targeted Anticancer Therapies

European Society for Medical Oncology (ESMO)

5-7 March 2018
Paris Marriott Rive Gauche Hotel & Conference Centre

The constant evolution of early phase development and translational research drove ESMO to enrich its meeting portfolio by acquiring the TAT Congress and providing a discussion platform focusing on new molecular targets and innovative cancer therapeutics.

A prestigious scientific committee, led jointly by G. Giaccone and J. Tabernero, designed a cutting-edge programme, establishing the TAT 2018 Congress as the premier international anticancer drug development meeting bringing together academia, industry, clinicians, researchers, scientists and regulators.

The goals and the design of phase 1 studies have changed from just safety/toxicity to now include clinical activity/response and biomarker research. This new phase 1 paradigm has already led to rapid, conditional, approval of several new cancer therapeutics showing outstanding clinical activity in early-phase studies.

TAT focuses on early-phase development and translational research. The programme will cover targeted agents, immuno-oncology and combinations involving such agents. We hope to see you at TAT 2018!

phone +41 (0)91 973 19 00
email esmo@esmo.org
web www.esmo.org
 
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Industry Events

Adaptive Designs in Clinical Trials

9-10 April 2018, Copthorne Tara Hotel, Scarsdale Place, Kensington, London, UK

Now running for 10 years, SMiís annual conference on Adaptive Designs in Clinical Trials will return to London on 9thand 10th April 2018. This yearís agenda has been curated to provide you with the latest innovations, regulatory updates, and strategies on how industry and clinical experts are currently using adaptive designs in their clinical trials for successful drug, medical device and therapy development.
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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News and Press Releases

York Health Economics Consortium offers a new health utilities training course

Cost-utility analysis is a requirement for NICE health technology appraisals and is being increasingly used in other contexts and countries. Health utilities, a crucial component of cost-utility analysis, capture the relative change in health-related quality of life resulting from a treatment. As such, health utility can be a key driver of the cost-effectiveness ratio. Obtaining health utility values that are suitable for your economic evaluation, however, may not always be straight forward.
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