Biotech Primer Institute

Drug Approval, Manufacturing Quality & Regulation

109 STUDENTS ENROLLED

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Course Running Time:
57 minutes | Assessment: 20 minutes
Course Material:
Downloadable PDF of all presented slides
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Pharmacokinetics & Pharmacodynamics

Drug Approval, Manufacturing Quality & Regulation discusses the major regulatory agencies involved in drug approval; the major steps required for preclinical and clinical testing; and post-approval pharmacovigilance. The course concludes with an overview of good manufacturing practices and validation procedures. Understand the pathway from the lab to the clinic. 

Regulatory Agencies & Compliance
At the end of this section you will be able to:
1. Discuss the guidelines regulatory agencies use to ensure a safe, effective and high quality drug supply

Preclinical Studies
At the end of this section you will be able to:
1. Understand the role of preclinical safety testing in the drug approval process

Pharmacokinetics & Pharmacodynamics
At the end of this section you will be able to:
1. Define Pharmacokinetics and pharmacodynamics

Clinical Development
At the end of this section you will be able to:
1. Compare and contrast clinical and surrogate endpoints
2. Describe in detail, the main purpose of each phase of clinical testing
3. Summarize the time cycle and cost for each phase of clinical testing
4. Compare and contrast the various desirable FDA designations- fast track, accelerated approval, priority review

Current Good Manufacturing Practices (cGMP)
At the end of this section you will be able to:
1. Explain the cGMP principles
2. Define the idea of Quality By Design (QbD) as it relates to enhancing manufacturability

Validation
At the end of this section you will be able to:
1. Describe the requirements for supplier and raw material validation
2. Explain the three types of qualifications required for equipment validation
3. Define process validation
4. Explain various methods used in testing validation

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