Revue de presse N°21

Revue de presse N° 21,  Mai 2017

Reality Check

International Clinical trials, winter 2017

CK Aspire’s Julie Millar, Gaynor Mates and Louise Doyle assess the role of the research nurse in real world studies for long-term medical conditions. The nurses are, they say, leading the way for recruitment and engagement.

http://www.samedanltd.com/magazine/13/issue/267/article/4531

 

RBM Adoption, Survey Time

International Clinical trials, Winter 2017

In a bid to improve quality and efficiency, change management practice is coming to the fore. Nicole Stansbury at PPD explores the implementation of risk-based monitoring and how surveys among clinical staff are aiding in driving this approach forward.

http://www.samedanltd.com/magazine/13/issue/267/article/4532

 

Mise en application du règlement européen relatif aux essais cliniques de médicaments : bilan à 1 an de la phase pilote – Point d’information

ansm 25/01/2017

Afin de préparer la mise en application[1]  du règlement européen relatif aux essais cliniques de médicaments à usage humain (Règlement UE n° 536/2014), l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) a mis en place une phase pilote, en lien avec des représentants des parties prenantes concernées : promoteurs académiques et industriels, comités de protection des personnes (CPP).

http://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Mise-en-application-du-reglement-europeen-relatif-aux-essais-cliniques-de-medicaments-bilan-a-1-an-de-la-phase-pilote-Point-d-information

 

Why Trump’s Latest Attack on the FDA Was Total Nonsense

Gizmodo.com, 30janvier2017

http://gizmodo.com/why-trumps-latest-attack-on-the-fda-was-total-nonsense-1792862548

 

Trump wants to blow up the FDA. The drug industry? Not so much

Statnews , By Damian Garde @damiangarde , February 1, 2017

https://www.statnews.com/2017/02/01/trump-blow-up-fda/

 

Data Integrity White Paper Alert

Life Science Panorama, February  24, 2017

Sound data is the foundation to good decisions and good science.  In the Life-Science industry patient outcomes, product quality, safety and efficacy all rely upon vast amounts of data that is generated throughout the product lifecycle.  This means that patients, brand equity and reputations have the potential to suffer greatly without a strong data integrity foundation.

http://axendia.com/blog/2017/02/24/data-integrity-white-paper-alert/

 

Google’s DeepMind Plans To Make Patients’ Health Records Trackable

 CIO TODAY, Posted March 12, 2017

Google’s AI-powered health tech subsidiary, DeepMind Health, is planning to use a new technology loosely based on bitcoin to let hospitals, the NHS and eventually even patients track what happens to personal data in real-time.

http://www.cio-today.com/article/index.php?story_id=03200113MRC0

 

Cybersecurity risks in medical devices are real

Life Science Panorama, March 13, 2017

Connected medical devices-like other computer systems-can be vulnerable to security breaches and have a potential major impact on safety and effectiveness of the device.  Specifically, in a healthcare environment, this vulnerability increases asmedical devices and medical equipment are becoming more connected through the internet to other medical devices, patients and/or to hospital networks (also referred to as the Internet of Medical Things).

http://axendia.com/blog/2017/03/13/cyber-security-risks-in-medical-devices-are-real/

 

IDMP: an International Standard for Lifecycle Data Management

Applied Clinical trials, April, 2017

The implementation of the International Organization for Standardization identification of medicinal products (IDMP) is a key step to ensuring that information on new innovations are identified and captured accurately within the regulatory framework and beyond.

http://www.appliedclinicaltrialsonline.com/idmp-international-standard-lifecycle-data-management

 

NHS Cyber Attack: a timely reminder we need preventative medicine

Pharma IQ, 16/05/2017

Ransomware attack could be wake-up call the healthcare sector needs to grasp importance of cyber security and the catastrophic cost of ignoring its threat. 

https://www.pharma-iq.com/medical-devices-and-diagnostics/articles/nhs-cyber-attack-a-timely-reminder