Generic Drug Development

Generic Drug Development

Generic drug products are defined as the substitutes of brand name drugs having the same dosage form, strength, safety, efficacy, and the route of administration as the original formulation. This short course focuses on the development processes and domestic and global regulations of the generic drug industry.

1,000.00
1000.0 ZAR 1,000.00
1,000.00
Last Update 29/09/2023
Members 0
Healthcare Course Hybrid On Campus Course Intellectus Campus South Africa Intellectus Campus Botswana Intellectus Campus Zimbabwe Intellectus Campus Namibia Intellectus Campus Zambia Intellectus Campus Eswatini Part time Full time

OVERVIEW


Generic drug products are defined as the substitutes of brand name drugs having the same dosage form, strength, safety, efficacy, and the route of administration as the original formulation. This short course focuses on the development processes and domestic and global regulations of the generic drug industry.

COURSE CONTENT


• Overview Of Drug Development 

• Good Manufacturing Practices

• Formulation And Development Process 

• Clinical Studies

• Analytical Chemistry

• Regulatory Affairs


ENTRY REQUIREMENTS


• A National Diploma in a pharmaceutical related science field.


DURATION


• 200 Hours to be covered over a maximum period of 3 months.


STUDY MODE

• Hybrid

COUNTRY

All Country Campuses

SKILLS YOU WILL DEVELOP


• Demonstrate an understanding of the roles of innovator drugs and RLDS in the generic drug development process

• Apply the principles of good manufacturing practices in the development of generic drugs.

• Demonstrate knowledge of the different Pharmaceutical dosage forms, equipment and container closure systems and how they are developed. 

• Demonstrate an understanding of the importance of clinical studies in the generic drug development process.

• Apply good laboratory practices principles in the development of generic drugs. 3.6 Outline regulatory requirements for submission of new products.


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