Amazing experience, lots of information!
A TGA visit was organised in September as a part of our class – Law, Ethics and the Regulation of Medicines. A variety of topics were covered during the two days – from pre-market, to evaluation of different types of medicines, to advertising, recalls and post market risk management plans. The evaluation process of prescription, OTC, complementary medicines were all covered to give us a good idea of the processes that these applications go through.
It was a very valuable experience for me. For each topic, I was able to connect it either to the course we were studying or to my current place of work. I was particularly interested in talks about Special Access Schemes, Orphan Drugs, Schedule 5A etc since these are some areas that my company is involved in. I’m responsible for preparing Schedule 5A reports every quarter. So it was quite interesting to be able to link the talks to the material covered in my current course as well as to my job and different departments within my company.
I paid attention to each speaker and asked lots of questions. No better way to learn than be inquisitive!
This visit gave me a comprehensive idea of how the different departments of TGA operate. It also made me realise the importance of having good working relationship with each department within the company since I have to liaise with them in my role as a Regulatory Affairs Associate.