Overview:

This workshop provides an overview of the information appropriate for new chemical entities, multisource medicines (generics), complementary medicines

Topics covered:

Non-clinical & clinical toxicity

Clinical efficacy and safety

Clinical trials & references

Overview:

This workshop provides an overview on the compilation of the professional information (PI) and patient information leaflet (PIL) of orthodox medicines, complementary medicines and veterinary medicines.

Topics covered:

Legal aspects

Format & Headings

Pharmaceutical aspects

Clinical aspects

References

Overview:

This workshop provides an overview of the evidence required to support administrative and substantive changes made by the applicant in support of quality, safety, efficacy of a product and pharmacovigilance changes to the professional information.

Topics covered:

a. EU, FDA and WHO Guidelines and frameworks

b. Classification and types of variations:

• Administrative
• Quality
• Safety, efficacy and pharmacovigilance
• Plasma master file & vaccine antigen master file

c. Submission procedures

Overview:

This workshop will clarify key concepts of biostudies and in vivo bioequivalence and appropriate methods for determining pharmaceutical bioavailability as surrogate for bioequivalence.

Topics covered:

a. Biostudies & Dissolution in Medicine Product Development

b. What a biostudy measures

c. Bioavailability and dosage form plasma profiles

d. Bioavailability and bioequivalence

e. Dissolution and biowaivers

f. Regulatory Tool:  Bioequivalence Trial Information Form

Overview:

This workshop provides an overview of the requirements and impact of the South African climate on warehousing, storage, and transportation.

Topics covered:

a. Properties of active substances and inactive pharmaceutical ingredients

b. Influence of climatic conditions/South African climate and classification

c. Stability testing requirements

d. Assessing the appropriateness of stability testing in South Africa & GMP compliance

Overview:

This workshop addresses the quality aspects of the active substance(s), inactive substances and final product to demonstrate the ability to consistently produce quality, safe, and effective medicines throughout the product life cycle.

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Topics covered:

a. Active substance master file (ASMF)/drug master file (DMF) (characteristics, route of synthesis, reference standard, validation, analytical validation, packaging)

b. Final product (product development and comparator products/reference product, description, characteristics, manufacture, validation, analysis, specifications & control, reference standards, analytical validation, container)

c. Quality overall summary

d. Manufacturing procedures & documentation

Overview:

This workshop provides an exploration of the diverse facets associated with overseeing the regulation of medicines, while aiding in fulfilling patients' requirements for accessible, affordable, safe, and high-quality medicines. Investigate the risk-based principles that underpin the development, production, distribution, control, and vigilance processes, ensuring the accessibility of quality medicines that are both safe and effective.

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Topics covered:

Birds eye overview of

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a. Pharmaceutical mishaps

b. Legal basis

c. Laws affecting medicines

d. SAHPRA Organisational structure

e. Medicine Registration

f. Medicine Regulation

g. Quality

h. Safety & Efficacy

i. Medicine Regulation Outcomes

j. The new drug development process

k. Structure, objective & scope of the CTD

l. Regulatory Compliance