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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

Dynascan Discusses Company Advancements With Packaging Today Magazine

Dynascan’s Marketing Manager (MM) recently met up with Europe’s leading packaging magazine, Packaging Today. During the interview many topics were covered, and you can read the full article here, but below are a few highlights and brief summary of what was discussed…
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White Papers

Conveying Medical Guidance in Clinical Trials – A Survey

Europital Medical Consultancy

With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project. When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
More info >>

Industry Events

PPMA Total Show

1-3 October 2019, Birmingham

About PPMA Total Show PPMA Total is one of UK’s largest processing and packaging machinery exhibitions. Building on the success of the PPMA Show in 2018, PPMA Total returns to the NEC, Birmingham, on 1-3 October 2019 for another show-stopping event.
More info >>

 
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