Clinical trials by Kyna Kwek https://padlet.com/kynakwek/9pbl45uouhcg7hh5 en-us 2023-11-02 03:57:52 UTC 2023-11-02 05:05:26 UTC hello@padlet.com HSA 210150251 https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773211567 2023-11-02 03:59:00 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773211567 Regulation of Clinical Trials https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773211769 2023-11-02 03:59:15 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773211769 IRB (Institutional Review Board) https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773212221

  • Protects the rights and welfare of individuals participating in research to ensure ethical research is being conducted


    • CTC - apply together with IRB

    CTN - must apply IRB first then CTN

    CTA - apply IRB at the same time

    ]]>     2023-11-02 03:59:43 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773212221     Medicinal Product 210150251 https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773213274

  • Health Products Supplement

  • Chinese Proprietary Medicines

  • Regulated by Medicines Act & Medicines (Clinical Trials) Regulations

    • ]]>     2023-11-02 04:00:50 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773213274     Therapeutic Products https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773213599

  • General Sales List

  • Pharmacy Only

  • Prescription Only Meds

  • Regulated by Health Products Act & Health products

    (Clinical Trials) Regulations

    • ]]>     2023-11-02 04:01:11 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773213599     class 2 CTGTP (Cell, tissue and gene therapy products) https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773214273

  • Regulated as they are of higher risk than class 1

    • ]]>     2023-11-02 04:01:53 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773214273     https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773214914

  • Observational clinical trials

  • Medical devices

  • Class 1 CTGTP

    • ]]>     2023-11-02 04:02:36 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773214914     CTA (Clinical Trial Authorisation) https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773215156

  • locally unregistered TP and class 2 CTGTP

  • unapproved use of a locally registered TP and class 2 CTGTP

  • registered but using for a new indication

  • new dosage forms

  • new dosing regime

    • ]]>     2023-11-02 04:02:53 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773215156     CTN (Clinical Trial Notification) https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773216180

  • registered products with approved labels

  • Involves only locally registered TP and class 2 CTGTP

  • Clinical research materials must be pre-approved

  • Placebos


    • ]]>     2023-11-02 04:04:02 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773216180     CTC (Clinical Trial Certificate) kynakwek https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773217031

  • For medicinal products (e.g. CPM)

  • if CRM is required, will be in same CTC application


    • ]]>     2023-11-02 04:04:59 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773217031     Required to comply with the requirements of the Human Biomedical Research Act https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773217242 2023-11-02 04:05:15 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773217242 Do not need dealer's license kynakwek https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773218415 2023-11-02 04:06:36 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773218415 Clinical Research Materials (CRM) https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773220090

  • Registered /Unregistered health products that are being used in the clinical research

    • ]]>     2023-11-02 04:08:28 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773220090     Product type: https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773222866 2023-11-02 04:11:49 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773222866 Key Regulations https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773223065 2023-11-02 04:12:03 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773223065 https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773224412

  • Therapeutic products

  • Class 1 CTGTP (manufactuere/importer/wholesaler notification has not been made to HSA)

  • Class 2 CTGTP

    • ]]>     2023-11-02 04:13:31 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773224412     https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773225337

  • Medicinal products

    • ]]>     2023-11-02 04:14:34 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773225337     https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773225575 Medical Devices

    ]]>     2023-11-02 04:14:48 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773225575     https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773226558 Health Products (CRM) Regulations

    ]]>     2023-11-02 04:15:43 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773226558     https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773227413 Medicines (Medicinal Products as CRM) Regulations

    ]]>     2023-11-02 04:16:42 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773227413     https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773227860 Health Products (Medical Devices) Regulations

    ]]>     2023-11-02 04:17:13 UTC https://padlet.com/kynakwek/9pbl45uouhcg7hh5/wish/2773227860