The Thalidomide disaster was a very important case which revolutionised how a medicinal product reaches the marketplace.’ In your opinion, discuss the impact the drug Thalidomide had on the regulations and how the tragedy helped shape the current quality system framework today.

‘The Thalidomide disaster was a very important case which revolutionised how a medicinal product

reaches the marketplace.’ In your opinion, discuss the impact the drug Thalidomide had on the

regulations and how the tragedy helped shape the current quality system framework today.

Include in your answer, the following criteria:

1. Chemistry of the drug and for what its intended use was.

2. Outline the regulatory requirements that were in place prior to the marketing of Thalidomide and

explain how this led to its approval and placement on the market

3. Outline the legislation put in place after the tragedy and explain how that has affected our current

quality systems to date and in your opinion what we have learned

4. Outline in detail the current uses of the drug and any contraindications applied to its use

The assignment should be between 5-7 pages long with a detailed reference section.