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Quad Pharma c.c.

Quad Pharma c.c.

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    • Accredited Short Courses
      • Medicines Registration Basic
      • The Preparation of the Clinical and Pre-Clinical Dossier
      • Medicines Registration Biological Medicines
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    • Targeted Training Courses
      • Bioavailability and Bioequivalence
      • Complementary Medicine – Health Supplements
      • eCTD Skills Training
      • Medicine Registration of Biosimilar Medicines and Bio-comparability
      • Medicine Registration in Sub-Saharan Africa
      • Package Insert and Patient Information Leaflet
      • Pharmacovigilance
      • The Responsible Pharmacist in Industry
      • Responsible Pharmacist Refresher
      • Marketing Code Compliance Officer
      • Variation Guidelines Workshop
    • GMP Targeted Training
      • SAHPRA Inspections
      • GMP for Importers
      • Master Documents
    • Professional Development
      • Business Writing Skills
      • Management and Leadership Skills
      • NBI – Thinking Styles
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      • Resolving Conflict
      • Stress Management
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Variation Guidelines Workshop

A one-day training workshop on EU Variation Guidelines as adopted by SAHPRA

Objectives:

  1. Introduction/Definition
  2. Understanding variation classifications
  3. Presentation of variations to facilitate review
  4. Grouping of variations
  5. Variations to multiple products
  6. Unforeseen variations
  7. SAHPRA Variations Addendum for Orthodox Medicines

Not in scope:

  • Clinical Variations
  • Biological medicines
  • Complementary medicines

Courses & Workshops

  • Accredited Short Courses
    • Medicines Registration Basic
    • The Preparation of the Clinical and Pre-Clinical Dossier
    • Medicines Registration Biological Medicines
    • Medicines Registration for Registration Assistants
  • Targeted Training Courses
    • Bioavailability and Bioequivalence
    • Complementary Medicine – Health Supplements
    • eCTD Skills Training
    • Medicine Registration of Biosimilar Medicines and Bio-comparability
    • Medicine Registration in Sub-Saharan Africa
    • Package Insert and Patient Information Leaflet
    • Pharmacovigilance
    • The Responsible Pharmacist in Industry
    • Responsible Pharmacist Refresher
    • Marketing Code Compliance Officer
    • Variation Guidelines Workshop
  • GMP Targeted Training
    • SAHPRA Inspections
    • GMP for Importers
    • Master Documents
  • Professional Development
    • Business Writing Skills
    • Performance Appraisals
    • Principles of Motivation
    • NBI – Thinking Styles
    • Management and Leadership Skills
    • People Development
    • Presentation Skills
    • Resolving Conflict
    • Stress Management

Upcoming Events

May
23
Mon
all-day SAHPRA Inspections
SAHPRA Inspections
May 23 all-day
To download a calendar & price list, click here.
May
24
Tue
all-day GMP for Importers
GMP for Importers
May 24 all-day
To download a calendar & price list, click here.
May
25
Wed
all-day The Responsible Pharmacist in In...
The Responsible Pharmacist in In...
May 25 – May 26 all-day
21-22 July – FULL 17-18 Nov – 4 of 4 available To download a calendar & price list, click here
  • About
  • Accredited Short Courses
  • Targeted Training Courses
  • GMP Targeted Training
  • Professional Development
  • Links & Downloads
  • Contact Us

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Contact

(+27)116220933 courses@quadpharma.com
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  • About
  • Accredited Short Courses
  • Targeted Training Courses
  • GMP Targeted Training
  • Professional Development
  • Links & Downloads
  • Contact Us