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raps (regulatory affairs professionals society)

  1. T

    MDR Guidance Book - Useful for MDR transition?

    Hi All, Whether MEDDEV guidance book will be useful for MDR transition? (It is released by RAPS) Is this book includes all MDR sections with detail explanations? Reference Link: https://www.meddevsolutions.co.uk/the-mdr-guidebook If anyone already bought this book suggest how much worth of...
  2. Marcelo Antunes

    FDA Considers Shift on Medical Device Quality System Regulations - 2018

    FDA Considers Shift on Device Quality System Regulations - maybe this time things will work out? FDA Considers Shift on Device Quality System Regulations | RAPS
  3. I

    Should I get IRCA ISO 13485 certification or RAPS certification?

    Dear all,i want you to advice me, what is better to get a IRCA ISO 13485 certification or to get a RAPS , i´m not talking about the content, i want to know about the chance to get a better job with this kind of certification. Thanks in advance.
  4. K

    RAPS RAC - Resources to prep for the RAC exam that don't cost an arm and a leg

    Any good resources to prep for the RAC exam that don't cost an arm and a leg? I've paid to become a member and to take the certification program but would just feel more comfortable with actual test prep.
  5. N

    Regulatory Affairs Certificate (Medical Device and Pharmaceuticals

    I am interested on getting a Regulatory Affairs Certificate (Medical Device & Pharmaceuticals). I searched a lot and I found out that Regulatory Affairs Professionals Society (RAPS) offers exactly what I am looking for. However, I would like to know if anyone heard about (RAPS) and their online...
  6. S

    RAPS Regulatory Affairs Certificate Program

    Hello, Has anyone taken up this course? I am new to this field, and just wanted to know, does taking up this course help with getting into the field of RA. I have Masters in Life Sciences. Thanks!
  7. M

    List of Contact Info for Asian Regulatory Authorities

    This convenient list of website addresses was published by RAPS: http://www.raps.org/Regulatory-Focus/News/Databases/2015/04/06/21908/The-Essential-List-of-Regulatory-Authorities-in-Asia/?utm_source=Email&utm_medium=Informz&utm_campaign=RF-Today
  8. G

    RAPS RAC - Regulatory Affairs Certification Help

    Hi Marc, I am newbie to Regulatory Profession as well to Elsmar!!! I find this forum of immense help for newcomers like me. Would you help me in guiding as to how and where I can get more knowledge about this field! Also suggest me reading materials that are easily available on net.. Your...
  9. S

    Mathematics for Regulatory Professionals - RAPS Focus Article

    Hi Covers, There is an interesting and useful article from RAPS Focus on Mathematics for Regulatory Professionals. Regards, Sreenu
  10. R

    RAPS Certification Exam Prep Study Group for Spring 2014

    Hi, I am preparing for RAPS certification exam for spring 2014 and would like to form a study group. Anyone interested please let me know! Thanks!
  11. S

    1st AHWP-RAPS Joint Conference @ KL, Malaysia 2-3 Dec 2013

    Hi All, Registration has opened for the 18th AHWP Meeting and 1st AHWP -RAPS Joint Conference. Event dates: 2-5 Dec 2013 Location: Petaling Jaya, Selangor, KL, Malaysia Early bird registration by 2 Nov 2013 Below is the url for more details: http://www.ahwp.info/index.php?q=node/342...
  12. S

    RAPS Article on STED (Summary Technical Documents)

    Hi All - This might be useful! Rgds, Sreenu
  13. S

    Proposed FDA Board of Directors - 2013

    http://www.raps.org/focus-online/news/news-article-view/article/3062/top-house-legislators-propose-fda-board-of-directors-to-oversee-agency/utm_source/social/utm_medium/post/utm_campaign/rfnews.aspx Very interesting, but would it really help or just add more red tape?
  14. P

    RAC (Regulatory Affairs Certification) US Spring 2013 Preparation Study Group

    Hello, I am currently preparing for RAC US exam 2013 Spring. I would like to start a study group and am happy to lead the study discussion. I am just checking to see if any one is interested.
  15. S

    FDA Enforcements for 2011 - RAPS article on FDA Inspections and Enforcements

    Hi, There is a RAPS article on FDA Inspections and Enforcements that summarizes the 2011 FDA Warning Letters, top ten deficiencies for Drugs, Devices, and number of domestic and foreign inspections, etc.. See attached presentation. Top ten medical device deficiencies according to FDA...
  16. bio_subbu

    GHTF issues guidance on Adverse Event Data Reporting Standard

    Dear All The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final guidance document on its N54:2006 adverse event data reporting standard. The...
  17. A

    ANVISA Strike to Delay Medical Device Reviews in Brazil

    :read:ANVISA strike to delay medical device reviews in Brazil htt p :// www .massdevice .com/blogs/arezu-sarvestani/anvisa-strike-delay-medical-device-reviews-brazil - OBSOLETE BROKEN 404 LINK(s) UNLINKED ANVISA Announces Continuity Measures for Medical Device Importers During Strike Global...
  18. G

    Preparing for RAC Exam - Need to take online-course at RASP?

    Dear All, Pls give me your valuable advice. I am considering to take the RAC exams and to initiate the registration of drug and food supplements from Asian countries with Health Canada and USFDA. In reviewing the preparation for the exams, I find it not clear to whether it is recommended to...
  19. A

    Preparing for the RAC Examination -- Developing an RAC Study Plan

    :agree1:Preparing for the RAC Examination -- Developing an RAC Study Plan
  20. bio_subbu

    GHTF Proposes New Harmonization of Medical Device Audits

    Dear All The Global Harmonization Task Force (GHTF), a medical device-focused regulatory harmonization organization which counts among its members many of the world’s top regulatory agencies, announced a new proposed medical device standard aimed at introducing a grading system to be used...
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