Drug Life Cycle

Laboratory
Operations
Quality
rd

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  1. Program Description
  2. Target Level
  3. Description
  4. Objectives and Expected Results
  5. Others Training Materials
  6. Target group
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Duration
1 day
Course fee
-

Program Description

Topics to be covered with this training includes:

  • Part1: Regulatory Affairs Definitions.
  • Part2: Brief View of Regulatory Landscape and Drug Lifecycle that includes:
  • Discovery and Preclinical Development.
  • Clinical Trials.
  • Dossier Writing.
  • Dossier Submission and Approval.
  • Marketing.
  • Post-marketing Responsibility.
Part3: An overview of the USA , Europe, and Jordan Regulatory Process.

Target Level

  • Graduated pharmacists.
  • Graduated Biotechnology students.
  • Regulatory Affairs specialists and officers in drug stores.
  • Regulatory Affairs specialists and officers in medical devices stores.

Description

Objectives and Expected Results

  • Participants will understand the basic definitions in regulatory terms.
  • Participants will be introduced to the drug life cycle from the discovery to the post-marketing phase.
  • Participants will take a general idea of the regulatory process and terminology in the USA, Europe, and Jordan.

Others Training Materials

  • A workshop and discussion question will be conducted during training.
  • Handout.

Target group

  • -

    Trainer Languages English/Arabic

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
[email protected]
00962 798756232