We found 405 records for "Regulatory / compliance"

Articles

Soliris, the world’s most expensive drug: will NICE judge it affordable?

13th August 2014

 Soliris, the world’s most expensive drug: will NICE judge it affordable? Articles

NICE and Alexion not budging on Soliris price - patient groups speak out in advance of ruling - decision will set precedent for rare diseases.NICE is on a collision course with...

Read more

Incretin-based anti-diabetic therapies: a pharmacovigilance perspective

12th August 2014

 Incretin-based anti-diabetic therapies: a pharmacovigilance perspectiveArticles

Incretin-based therapies have advanced treatment of type 2 diabetes but have been linked to pancreatitis and pancreatic cancer in some patients. Conflicting evidences for and against this suspicious link has...

Read more

Adaptive Licensing: Could patients be the answer to the data problem?

4th August 2014

 Adaptive Licensing: Could patients be the answer to the data problem?Articles

Patients could play a key role in generating the data required to make Europe's Adaptive Licensing a success.The timing of patient access to new medicines has always been one of...

Read more

Translation from research to clinical significance - a due-diligence analysis

1st August 2014

 Translation from research to clinical significance - a due-diligence analysis Articles

Translational research partnerships help turn academic excellence into new treatments for patients – but they require due diligence at every step along the way.The general public perceives research to be...

Read more

News

NICE yes for Revlimid after price limit

20th August 2014

 NICE yes for Revlimid after price limitNews

NICE has recommended Celgene's Revlimid (lenalidomide) as an option for treating myelodysplastic syndromes.The institute has reversed its opinion of the drug in its final draft guidance after Celgene provided further evidence to...

Read more

Diabetes drug Basaglar receives tentative FDA approval

19th August 2014

 Diabetes drug Basaglar receives tentative FDA approvalNews

The FDA has granted tentative approval for Basaglar (insulin glargine injection), produced by Eli Lilly and Boehringer Ingelheim's (BI) diabetes alliance, following litigation filed by Sanofi claiming patent infringement.The terms...

Read more

Eisai ‘outraged’ by decision on epilepsy drug

18th August 2014

 Eisai ‘outraged’ by decision on epilepsy drugNews

A ruling in Germany which has found Eisai's epilepsy drug Fycompa to have no extra benefits to existing treatments has been heavily criticised by the company and leading specialists.The company...

Read more

NICE to re-evaluate Firmagon for advanced hormone-dependent prostate cancer

18th August 2014

 NICE to re-evaluate Firmagon for advanced hormone-dependent prostate cancerNews

A successful appeal against NICE's decision on prostate cancer drug Firmagon (degarelix) means the UK's cost-effectiveness regulator will re-examine the evidence for its use in advanced cases of the disease.At...

Read more

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...

Read more

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...

Read more

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...

Read more

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...

Read more

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...

Read more

Events

4th Annual MARKET & PATIENT ACCESS in LATIN AMERICA

19th August 2014 - 20th August 2014

4th Annual MARKET & PATIENT ACCESS in LATIN AMERICA

This two-day event will allow all participants the ability to learn about the current market access approaches which are required for each market in order for them to have greater...

Read more

Pharmaceutical Congress Asia

26th August 2014 - 29th August 2014

Pharmaceutical Congress Asia

The Pharmaceutical Congress Asia recognizes the importance of strong partnerships to drive innovation, development and winning products and services in Asia’s growing pharmaceutical industry. Packed with case studies from market...

Read more

4th Annual Pre-Filled Syringes 2014

2nd September 2014 - 4th September 2014

4th Annual Pre-Filled Syringes 2014

A three day solution-led and networking conference, the agenda has been designed exclusively by drug developers to help you drive device and combination product innovation, ensure regulatory compliance and optimize...

Read more

Analytical Method Development, Validation and Transfer

9th September 2014

Analytical Method Development, Validation and Transfer

Informa life Sciences' Analytical Method Development, Validation and Transfer is a dedicated forum focusing solely on new method development, validation and transfer for pharmaceutical and generics manufacturers. The event is...

Read more

Press Releases

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...

Read more

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...

Read more

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...

Read more

Ashfield Commercial & Medical Services redefines healthcare outsourcing to meet pharma's challenges

5th February 2014

Ashfield Commercial & Medical Services redefines healthcare outsourcing to meet pharma's challenges

  Ashfield Commercial & Medical Services   redefines healthcare outsourcing to meet pharma’s challenges   03 February 2014: UDG Healthcare plc (formerly United Drug plc), a leading international provider of services to healthcare manufacturers...

Read more