We found 635 records for "Regulatory / compliance"

Articles

Market access for new specialist drugs will get harder, says NHS England

2nd July 2015

 Market access for new specialist drugs will get harder, says NHS EnglandArticles

Andrew McConaghie reports on a frank exchange of views about NHS finances and market access in the UKPharma's late-stage pipeline may be dominated by a new generation of specialist, often groundbreaking...

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Gathering real-world evidence in the early access setting

1st July 2015

 Gathering real-world evidence in the early access settingArticles

Early access programmes offer the potential for gaining real-world evidence in the period between phase III and marketing authorisation, which could provide data to support the product's effectiveness and value...

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Best practice in health outcomes research

26th June 2015

 Best practice in health outcomes research Articles

Nicola Bonner clarifies the guidelines, and which are relevant, to ensure practitioners maintain high and consistent standards.Qualitative and quantitative non-interventional health outcomes research studies are on the increase, but there...

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UK pharma disclosure of payments: lessons from the US Sunshine Act

22nd June 2015

 UK pharma disclosure of payments: lessons from the US Sunshine ActArticles

In the second article on pharma's disclosure of payments in the UK, Andrew McConaghie talks to the PMCPA's Heather Simmonds about potential complaints, and lessons from the US.The pharma industry...

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News

More cystic fibrosis patients to get Kalydeco in England, but delay criticised

3rd July 2015

 More cystic fibrosis patients to get Kalydeco in England, but delay criticisedNews

More patients with the life-limiting disease cystic fibrosis are to receive new treatment Kalydeco, after NHS England agreed to fund the drug.But charity the Cystic Fibrosis Trust has hit out...

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Boehringer secures first European approvals for new COPD treatment

2nd July 2015

 Boehringer secures first European approvals for new COPD treatmentNews

Boehringer Ingelheim has secured first European approvals for its new once-daily treatment for chronic obstructive pulmonary disease, Spiolto Respimat. The drug combines the long-acting muscarinic agonist tiotropium - the active ingredient...

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Novo Nordisk pulls Tresiba from Germany in protest at pricing

2nd July 2015

 Novo Nordisk pulls Tresiba from Germany in protest at pricingNews

Novo Nordisk has become the latest drugmaker to refuse to supply one of its diabetes products in Germany after failing to agree a price with the national body representing health...

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UK backs early access to BMS’s Opdivo for lung cancer

1st July 2015

 UK backs early access to BMS’s Opdivo for lung cancerNews

Patients with lung cancer in the UK can now get treatment with Bristol-Myers Squibb's Opdivo under a new scheme designed to accelerate access to new drugs.Opdivo (nivolumab) has been included...

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White Papers

"The future ain’t what it used to be"

25th November 2014

 "The future ain’t what it used to be"White Papers

Preparation is key to creating and maintaining a strong drugs pipeline. However, the statistics demonstrate that successful product commercialisation strategies are not always implemented. Products are developed for which there...

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Healthcare Innovation: the big ideas shaping the future of pharma

17th November 2014

 Healthcare Innovation: the big ideas shaping the future of pharmaWhite Papers

The transformation taking place in healthcare is challenging for everyone and adaptability is key for the pharma industry's continued success.Long production cycles, concentration on specialist drugs with high price tags,...

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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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Audio & Video

Available on demand: Effectively using real-world data for commercial success

  Life sciences companies need to make better use of the insights that real-world data (RWD) can provide in order to improve market access, sales and market growth strategies – and...

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Live webinar/debate - Feb 4th - COPD, connecting real world needs to patient centric solutions

    COPD is a widespread, costly and largely preventable condition which affects over 300 million people worldwide and is recognised as the ‘third-leading’ cause of death in most countries. Adherence rates...

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Events

Pharma Serialization: FMD Strategy

15th July 2015

Pharma Serialization: FMD Strategy

The Falsified Medicines Directive introduces the requirements for the outer packaging of certain medicines to include unspecified safety features which allow wholesale distributors and others who supply medicines to the...

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The Global Response to Ebola: Implications for Future Drug and Vaccine Development

15th July 2015

The Global Response to Ebola: Implications for Future Drug and Vaccine Development

The Ebola epidemic, which tore through West Africa in 2014, and continues to pose a huge global health challenge, has prompted unparalleled collaboration between worldwide academia, industry and government. This...

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8th Annual Pharmaceutical Regulatory Affairs Asia

3rd August 2015 - 6th August 2015

8th Annual Pharmaceutical Regulatory Affairs Asia

The current Asian regulatory environment features fast-paced changes in regulations, varied interpretation of guidelines, lack of transparency in processes and delayed timelines for approval. The 8th annual event will address...

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3rd Annual Market Access & Commercial Excellence Forum Asia 2015

5th August 2015 - 6th August 2015

3rd Annual Market Access & Commercial Excellence Forum Asia 2015

This 2 day event will look at how both developed and developing Asian healthcare systems are growing and how stakeholders and patients are increasingly demanding quality care and “value.” Commercial...

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Press Releases

The REAL WORLD Challenge: Are you maximising the effectiveness of RWE?

20th April 2015

The REAL WORLD Challenge: Are you maximising the effectiveness of RWE?

RWE is now recognised as critical to all commercial activities and is becoming embedded across the life-science industry. pH Associates is hosting a summit on May 5th (4-7pm) that will take a fresh look...

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Arthur G. Cook (ZS Associates) publishes 2nd Edition with Gower

15th April 2015

Arthur G. Cook (ZS Associates) publishes 2nd Edition with Gower

  The eagerly awaited second edition of Arthur G. Cook's Forecasting for the Pharmaceutical Industry is now available from Gower.     Forecasting for the Pharmaceutical Industry is a definitive guide for forecasters as...

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Veeva Systems Introduces Veeva OpenKey

24th March 2015

Veeva Systems Introduces Veeva OpenKey

  Veeva Systems has launched Veeva OpenKey, a new type of customer data solution for the life sciences industry.  As the life sciences business continues to diversify across borders and new channels,...

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Adelphi Research UK Refreshes Corporate Brand & Positioning

4th March 2015

Adelphi Research UK Refreshes Corporate Brand & Positioning

    Adelphi Research UK has a strong heritage of providing robust market research in the healthcare sector. Established since 2000, they have extensive expertise in pharma, and also span OTC and...

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