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INDUSTRY NEWS AND PRESS RELEASES

Are you keeping up to date with changes to pharmaceutical laws and guidance?


The legal and regulatory environment affecting the pharmaceutical industry is in a period of unprecedented change. Are you keeping up with all these changes?

• Brexit is very close, with massive implications for pharmaceuticals being reflected in guidance from both the EMA and the UK government
• New, separate EU GMP legislation for both marketed and investigational products linked to the implementation of the CT Regulation
• The implementation for ‘Safety Features’ is upon us
• A new regulation for medical devices which will have a significant impact on combination products
• Implementation of the MRA between the EU and the USA
• Changes to the scope of the EU-Japan MRA
• The draft revision of EU GMP Annex 1 on Sterile Products
• Revised versions of EU GMP Annexes 2,13 and 17
• The proposed new EU GMP Annex 21
• The new EU GMP Part IV on Advanced Therapy
• The draft of ICH Q12 on Lifecycle Management
• Proposed revision of ICH Q2 and new ICH Q13 and 14
• Significant reorganisation with in the US FDA
• The FDA implementing new inspections protocols for aseptically produced products

To say current come to Pete Gough’s Pharmaceutical Legislation Update day in either Manchester, UK, on 19 March or Amsterdam on 21 March 2019 and make sure that you remain in compliance.

Discounts are offered to NHS staff, regulators and charities and for companies sending more than one delegate.

Pharmaceutical Legislation Update – 19 March, Manchester, UK

Pharmaceutical Legislation Update – 21 March, Amsterdam, Netherlands Have a question? Contact our friendly team at pharmacourses@nsf.org
 
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News and Press Releases

Sphere Fluidics hires 10 new UK and US staff in its plan to scale internationally

Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, announced today that it has appointed six new employees and plans to hire four more staff in its UK and US sites. Rob Treanor and Andrew Campbell join Sphere Fluidics as Director of Operations and Director of Finance, respectively alongside new hires to its sales, operations and scientific teams. These appointments will expand the Company’s commercial capabilities and facilitate service and support for new and existing Cyto-Mine® customers in both the UK and US.
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White Papers

e-tools enhance clinical trial performance

e-novex

In today’s ever-evolving medical business, technological changes require innovation to meet growing market demands and to bring about advances in the industry. One such development currently taking place in the field of clinical research is how e-tools are initiating a boost in the productivity of clinical trials.
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Industry Events

Clinical Trial Supply Global Forum

20-22 May 2019, Brussels, Belgium

You can’t get a drug to market without a clinical trial. You can’t run a clinical trial without product supply. We understand that your role is critical in ensuring the on time and efficient development of the next life saving drug and we know that this makes your time precious. In 2019 we have condensed everything you need to advance your Clinical Trial Supply into three jam packed days. The industry's most interactive and solution focused CTS forum features deep dive workshops, live polls, panel debates, round table discussions and exclusive key note case studies to ensure that you leave with the industry's best solutions and strategies to transform your clinical trial supply. If there is ONE Clinical Trial Supply conference that you attend in 2019, make sure that it is this one.
More info >>

 
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