@CriterionEdge

The regulatory, scientific, and medical writing experts. #Biotech #Pharma #Biologics #IVD #RegulatoryWriting

 San Luis Obispo, CA
criterionedge.com
Joined April 2017
  • Tweets1.1K
  • Following69
  • Followers95
231Media
#RAPSEuroConvergence is off to a great start after an excellent opening plenary on leveraging joint clinical data 📊
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Criterion Edge retweeted
ESCMID@ESCMID26 Apr 2022
#ECCMID2022 in Lisbon has officially ended and we want to thank everyone who has made this return to onsite ECCMID such a success! We hope that you enjoyed your time and we can't wait to see you again next year in Copenhagen for #ECCMID2023!
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#IVD manufacturers currently have access to only 6 #notifiedbody designations. Where do you find the lack of notified bodies impacting your organization the most? #EU #IVDR bit.ly/3qfs70r
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Join RAPS and @CriterionEdge this Wednesday, 22 January from 12 - 1 pm Eastern Time, for a webcast focusing on the use of Systematic Literature Review to meet MDR requirements. Sign up to attend - bit.ly/2sN092o #EUMDR #RegulatoryAffairs
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Criterion Edge retweeted
DistillerSR@evidencepartner4 Nov 2019
Regulatory requirements are increasing. Make sure your #SystematicLitReviews are compliant by attending our next #FreeWebinar on Nov. 13 with @CriterionEdge. Sign up right here: hubs.ly/H0lx4HY0
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Criterion Edge retweeted
Generis Group@GenerisGP30 Sep 2019
Do you know the 5 key questions to help manage your budget? @CriterionEdge states in order to thoroughly comply with regional #regulations and rigorous #standards, companies need strategies to keep the #budget for #medical writing in check. Learn more: bit.ly/2nOVt9o
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Criterion Edge retweeted
Generis Group@GenerisGP16 Sep 2019
Experienced in all phases of drug, biologic and #medicaldevice product development, the @CriterionEdge project managers and #regulatory writers provides their clients state-of-the art regulatory writing service. Learn more: bit.ly/32LR1ra #regulation #safety #pharma
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Explore the implications of the EU MDR and IVDR on the collection, triage, management, and reuse of data for regulatory purposes with Evidence Partners CEO and the rest of our expert panelists at MedTech Summit @MedTech365 @criterionedge hubs.ly/H0hXs9W0
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Criterion Edge retweeted
Xtalks Webinars
@Xtalks14 Nov 2018
State of the Art Literature Review for @EUMDR Compliance: How To Get It Right Did you know that the term “state of the art” appears approximately 39 times in MEDDEV 2.7/1 rev. 4. Learn more from the experts @evidencepartner @peteroblenis & @CriterionEdge buff.ly/2SfSYr5
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A sticky situation - will your labels comply with EU #MDR? buff.ly/2CUemOy via @HealthcareGlbl #IVD
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CE's VP of Scientific and Medical Affairs, Kyoto Hattori, will be leading our next free #webinar on Endpoint Adjudication by the Clinical Endpoints Committee. Sign up: bit.ly/2nXGZR4 Wednesday September 12, 11am PST | 2pm EST #ClinicalResearch #AdverseEvents @emanatels
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Innovation is the life blood of the #medtech industry. Read @MedTech_Insight’s interview with #JNJ’s @MirrenMandalia to find out how we help turn great ideas into a reality: bit.ly/2vOA7t8
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MHRA fees for 2018/19, including clinical investigations for #medicaldevices and #drug/device combination fees are remaining the same as 2017/18 #medtech bit.ly/2cl2NBf
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Post Edited: Resolving the Challenges of Connectivity, Competition & Compliance for Modern Medical Device Makers businesstechinsider.com/reso…
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5 cool #healthcare #tech innovations seen so far in 2018 | bit.ly/2LEwfWc v/ @tech9tification @IrmaRaste @eViRaHealth @evankirstel @HealthcareLdr @sminaev2015 #healthtech #health #medical #medtech #digitalhealth #ehealth #innovation #digitaltransformation #emergingtech
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Criterion Edge retweeted
Pink Sheet@PharmaPinkSheet31 Jul 2018
Gottlieb's "Right To Try" Sentiment: Law Fails To Address Difficulties Faced By Drugmakers bit.ly/2mWdrmr #PinkSheet
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Do you know the three basic steps to #pharmacovigilance? Learn about them in AfPA's video: bit.ly/2ENkb1z
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What's the state of #pharmacovigilance in the European Union? Read @EMA_News annual report to find out! xitter.cf/EMA_News/status/100398…
EU Medicines Agency
@EMA_News5 Jun 2018
#AnnualReportEMA - Experts reflect on how EU #pharmacovigilance system has changed in the last five years bit.ly/2rl0X9M
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No standards exist for teaching #pharmacovigilance at universities, so a core curriculum needs to be developed. Here’s what Lareb, @WHO, @univgroningen, @UtrechtUni, @UniVerona and @OmaniMOH propose in #DrugSafety: ow.ly/BlgZ30kPkQX
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EU's New #MDR/#IVDR Governance Group: What's At The Top Of Its Agenda? medtech.pharmaintelligence.i… via @Medtech_Insight
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