We found 451 records for "Regulatory / compliance"

Articles

Cancer drugs: value is about more than cost

23rd October 2014

 Cancer drugs: value is about more than costArticles

When assessing the true value of cancer drugs, collaboration with key stakeholders, reform of the development process and reimbursement system, and a true understanding of what is important to the...

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NICE and the 2015 General Election

22nd October 2014

 NICE and the 2015 General ElectionArticles

What could the forthcoming UK General Election in May 2015 mean for the always evolving National Institute for Health and Care Excellence (NICE)? Leela Barham takes a look at how...

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Social enterprises: doing NHS business without the bureaucracy

20th October 2014

 Social enterprises: doing NHS business without the bureaucracy Articles

Nisha Desai, head of medicines management at social enterprise company Provide, speaks to pharmaphorum about how such organisations are benefitting the NHS, prior to her appearance at a major London...

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Pharma gets social: US FDA in Ebola social media crackdown

16th October 2014

 Pharma gets social: US FDA in Ebola social media crackdownArticles

This month, Daniel Ghinn turns the spotlight on companies claiming to sell 'cures' for Ebola via social media channels and looks at how the US FDA is responding."This is to...

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News

FDA panel backs wider use of Vertex cystic fibrosis drug

22nd October 2014

 FDA panel backs wider use of Vertex cystic fibrosis drugNews

More cystic fibrosis patients in the US should be eligible for treatment with Vertex Pharma's Kalydeco therapy, according to an FDA advisory committee.Yesterday the expert panel voted 13 to two...

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UK experimental drugs bill 'could hit clinical trial recruitment'

21st October 2014

 UK experimental drugs bill 'could hit clinical trial recruitment'News

Patients in England and Wales will be able to get access to experimental medicines from next March if a new bill is adopted - but there are fears the measures could...

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NICE swayed by long term Glivec data

17th October 2014

 NICE swayed by long term Glivec dataNews

NICE has reversed a long-standing block on using Glivec in GIST tumours, saying new evidence has persuaded it to change its mind.Final draft guidance published today proposes to recommend Novartis' Glivec...

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Roche tipped to lead Boehringer in IPF head-to-head

16th October 2014

 Roche tipped to lead Boehringer in IPF head-to-headNews

Patients in the US with serious lung disease idiopathic pulmonary fibrosis (IPF) have gone from no approved drugs to two after the FDA cleared products from Roche and Boehringer Ingelheim.The green...

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White Papers

How pharma Tweetchats can drive healthcare innovation

29th April 2014

 How pharma Tweetchats can drive healthcare innovationWhite Papers

During the course of 2013 Boehringer Ingelheim explored the use of multi-way communication on Twitter, via Tweetchats, as a means to better understand disease area issues and directly connect with...

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Who are the pharma social media butterflies?

19th March 2014

 Who are the pharma social media butterflies?White Papers

Social media has got everyone talking and it seems like everyone in pharma is talking about social media, so Ogilvy Healthworld figured it was time to analyse who were the...

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Engage with confidence: Managing online adverse event reporting

18th March 2014

 Engage with confidence: Managing online adverse event reportingWhite Papers

The pharmaceutical industry is waking up to the enormous potential offered by social media and other online data sources for informing better decisions around drug development and commercialization. Here, Siva...

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The Healthcare Meetings Forum 2013

22nd October 2013

 The Healthcare Meetings Forum 2013White Papers

Healthcare meetings are experiencing a time of change, as new compliance regulations, the rise of digital and the flexing needs of healthcare providers force adaptation. This has raised concerns across...

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Audio & Video

Rare Disease Day tweetchat

  To view a full transcript of the discussion from this #hcsmeu tweetchat held on 28th February 2014 please click here. During the hour-long tweetchat, we covered the following questions:   1) What are...

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Events

Global eSubmissions

21st October 2014 - 23rd October 2014

Global eSubmissions

Europe’s only electronic submissions conference focusing solely on eSubmissions for regulatory operations and submissions teams. Exclusively featuring the latest EU telematics initiatives, regulatory authority feedback and industry benchmarking ...

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Pharma Logistics Africa

21st October 2014 - 23rd October 2014

Pharma Logistics Africa

IQPC South Africa, in partnership with The Federation of East African Pharmaceutical Manufacturers (FEAPM), is pleased to announce Pharma Logistics Africa 2014, taking place from 21 – 23 October 2014...

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Practical GCP Compliance Auditing of Trials and Systems Training Course

22nd October 2014 - 24th October 2014

Practical GCP Compliance Auditing of Trials and Systems Training Course

This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemented in the EU, Japan and the...

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Training Course on Biopharmaceuticals, Biosimilars and Advanced Therapies - Development and Regulatory Framework in Europe

22nd October 2014 - 24th October 2014

Training Course on Biopharmaceuticals, Biosimilars and Advanced Therapies - Development and Regulatory Framework in Europe

The scientific basis and data requirements for dossiers at different stages of development will be communicated for the quality, preclinical and clinical parts of regulatory submissions. Case-studies will be inserted...

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Press Releases

3 TIPS FOR PATIENT ENGAGEMENT; DEFINE, ACT THEN ACCELERATE

23rd September 2014

3 TIPS FOR PATIENT ENGAGEMENT; DEFINE, ACT THEN ACCELERATE

Forbes blogger Leonard Kish described “patient engagement as the blockbuster drug of the century” namely for its potential impact on improving patient outcomes. Two years on from his article, I asked;...

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PMCPA selects The EarthWorks as communications partner and app developer for new code

28th July 2014

PMCPA selects The EarthWorks as communications partner and app developer for new code

The Prescription Medicines Code of Practice Authority (PMCPA) announced today that it will be working in partnership with The EarthWorks to create a communications programme, including an app to help...

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New WMF article on global healthcare gaps published

29th May 2014

New WMF article on global healthcare gaps published

WMF recently published an article in Pharmaceutical Physician, which looks at the shocking gaps in healthcare that exist across the world and summarises how the organisation is helping to improve...

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Industry and the NHS - can promotion and partnership co-exist … a debate hosted by the PM Society Market Access Interest Group …

11th February 2014

Industry and the NHS - can promotion and partnership co-exist … a debate hosted by the PM Society Market Access Interest Group …

  Chair: Beverly Barr, Vice-Chair and Market Access Lead, PM Society Panel: Di Vegh, NHS Partnership Manager, ABPI:  How to avoid divorce in your NHS partnerships   Felicity Greene, Director of Operations at NHS South...

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