EMEA mandates electronic submissions by 1 January 2010
The European Medicines Agency (EMEA) has issued a reminder that the Electronic Common Technical Document (e-CTD) format will be mandatory for marketing authorization applications for medicinal products for human use from 1 January 2010. More...
Most firms meet postmarketing study timelines
More than 80% of pharmaceutical and biologics companies are completing their postmarketing studies and regulatory obligations in a timely manner, according to the FDA. More...
Controlled-release formulations targeted by generics companies
Generic drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in August 2009. More...
EC backs nanotechnology with 1 billion euros
The European Commission (EC) has made 1 billion euros available for new projects involving micro and nanotechnology. More...
Pfizer takes $2.3 billion hit
Pfizer will pay $2.3 billion to settle the investigation with the US Department of Justice regarding the off-label promotion of Bextra. More...
Encap's deal to target colonic drug delivery
Encap Drug Delivery (UK) has licensed a coating technology that targets the release of drugs to the colon. More...
Join PTE on LinkedIn!
Join Pharmaceutical Technology Europe's group on LinkedIn. More...
FDA seeks data for Sentinel Initiative
The FDA plans to begin collecting information for its Sentinel Initiative, according to
the
Federal Register announcement. More...
Dainippon Sumitomo Pharma to acquire Sepracor
In a move designed to increase its position in North America, Dainippon Sumitomo Pharma (DSP, Japan) has agreed to acquire the specialty pharmaceutical company Sepracor (MA, USA) for $2.6 billion. More...
| World Drug Manufacturing |
2–4 December 2009
Germany
How will drug manufacturing respond to the current global recession? The current economic crisis affects everyone, however the drug manufacturing industry can continue to thrive through cost of goods reduction, increasing productivity and promoting efficiency. World Drug Manufacturing 2009 is the only conference and networking event this year to give you the strategies to continue to be successful through the challenging times ahead.
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| Property Measurement and Testing of Powders for Pharmaceutical / Neutraceutical Production |
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29 September 2009
UK
A one-day seminar hosted by the University of Greenwich focusing on the practicalities of achieving and maintaining production of high quality products whilst minimising the generation of out-of specification materials. The day represents an opportunity to familiarise with some of the latest scientific techniques for improving formulation and processing performance.
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| Biology Technician — Production, Council of Europe |
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European Directorate for the Quality of Medicines & HealthCare
The Council of Europe, based in Strasbourg, France, is a political organisation founded in 1949 to promote greater unity among its member States. Today its membership numbers 47 States across Europe, working together to promote democracy, human rights and the rule of law and to develop common responses to political, social, cultural and legal challenges.
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