CEP approval [Regulatory submission to Europe-API]

CEP is an approval given to API, excipient, herbal substances and TSE risk substances listed in European pharmacopoeia. As CEP certificate is accepted worldwide, Indian manufacturers prefer this option and get huge business/ revenue. India has the maximum number of CEPs and holds 2nd position worldwide. Thus it is utmost important to learn and understand CEP procedure in detail through this short course.

Category: Crash Courses
Duration : Training duration: 4 hours, course would be accessible for 1 month from the date of admission

Learning objectives

This course gives you insight into CEP procedures sequentially from submission to approval in a simpler way. It covers introduction, approval process & certification, inspection program, suspension withdrawal & closure. It also discusses how to address changes in CEP. This knowledge will give you the confidence to face interviews successfully. 
 

Eligibility

B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.

Syllabus

  • Section 1: CEP submission 4 hours

    • EDQM, CEP, Application form, QOS, Evaluation, approval, certification database, validity, inspections 151 minutes
    • CEP: Suspension, withdrawal, closure, revision & renewal 95 minutes

Fees : 3776

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    Course Include :
  • Video
  • PDF
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