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@arisglobalsolution-blog
Join our upcoming clinical free webinar on April 16, 2015 to understand the problems associated with EDC integration, Scope’s experience with integrating multiple applications and the advantages of a unified approach. #clinicaltrials #CRO #CTMS #clinicalresearch#clinicaldevelopment #Lifesciences #biotech #pharmahttp://bit.ly/1xB9XCE
One day to go!! Don't forget to register for our free webinar on March 20, 2015 to understand the Scope of ISO IDMP 11615 Standard. #IDMP#pharmaceuticals #biotech #regulatoryaffairs #lifescienceshttp://bit.ly/195occH
Road to IDMP (Identification of Medicinal products).
Meet us @ACDM Annual Conference 2015. http://bit.ly/1GnEBob#clinicalresearch #Clinicaltrials
Don't forget to register for our upcoming complimentary #clinical webinar "Integration Paves the Way: Overcoming the Challenges & Complexities of Today's Clinical Development Environment" on May 06, 2015 @11 AM EDT. #Clinicaltrials #clinicalresearch http://bit.ly/1EpFklZ
FDA issues revised Draft Guidance for Industry on Disclosing Risk Information in Consumer-Directed Print #Advertisements and Promotional #Labeling for Human #PrescriptionDrugs
The revised draft guidance includes recommendations to standardize the information consumers receive in print prescription drug product advertisements and promotional labeling and to make information more understandable to consumers. It provides recommendations for developing a consumer brief summary, clarifies the risk information that should be included in the consumer brief summary and provides additional guidance regarding ways to present this information d. http://1.usa.gov/16MGZcj
Which Signature to Use? Everybody knows how to sign a document – at least in the good old times when paper was used. Just take a pen and put your name on the piece of paper. We have been using this technology for many centuries and it is a global standard. #electronicdocument #clinicaldocument #clinicalresearch http://bit.ly/1AWSISf
Creating Your Short List of Q1 Industry Conferences to Attend. The first few months of every year launches the initial round of industry #conferences and trade shows for those within the #clinicaltrial development industry. With so many to choose from, deciding which ones deserve your commitment and budget to attend takes research and time before you can reach a decision. #Meet #ArisGlobal http://bit.ly/1E03V26
#FDA releases guidance for industry on Individual Patient Expanded Access Applications: Form #FDA-3926
U.S FDA releases guidance for industry on Individual Patient Expanded Access Applications: Form FDA 3926: This guidance introduces and describes draft Form #FDA-3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND).http://1.usa.gov/1uDHboF
U.S FDA releases guidance for industry on Individual Patient Expanded Access Applications: Form FDA 3926: This guidance introduces and describes draft Form #FDA-3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND).http://1.usa.gov/1uDHboF
US #FDA Issues Final Guidance on #Mobile #Medical Applications.
#Mobile medical apps as defined in section III include only those mobile apps that meet the statutory definition of a device and either are intended. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). http://1.usa.gov/1baa4bO
Pfizer Improves Access to #MedicalInformation: Traditionally Medical Information teams at pharmaceutical companies are not very visible. They usually do not advertise their services for fear of being perceived as promotional. At many companies Medical Information teams guard their content and services and protect their practice with iron clad SOPs to avoid influence from promotional teams. #medicalaffairs http://bit.ly/1z6Xbwb
Physician Payment #SunshineAct: Bipartisan Members of Congress Introduce Bill to Exclude Educational Materials From Reporting, Including CME and #Medical Texts
.http://bit.ly/16R00cW
France's #ANSM Says it Wants to Study Use of #Medicaldevices
According to ANSM, special attention will be paid to projects to study the safety of use in real-life medical devices and/or the impact of physical/societal risks related to medical devices and new technologies. http://bit.ly/1uc87GE
US New Bill Make it Easier for the Poor to Participate in #ClinicalTrials.
A bipartisan bill that aims to expedite the release of new treatments by modernizing clinical trials is in the works.http://1.usa.gov/1uc63hK
ICH: Update on #E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files! ICH constrained the ISO ICSR standard to meet the data exchange requirements for E2B(R3). ICH defines the way that this standard should be used by means of the ICH Implementation Guide (IG) which covers the use of the fields defined by E2B(R3). #Pharma. #pharmacovigilance. https://lnkd.in/eEuzjBg
#IMDRF has released the final list of recognized international standards for#medicaldevice. The concept of the use of recognized/mandatory standards is currently implemented in the different IMDRF jurisdictions in different ways. http://bit.ly/1zo8aCs