Pharmaceutical studies (currently completing thesis for PharmD)
Master’s 2 degree in International Development and Registration of Drugs
agap2 current project:
Animal Health Regulatory Affairs Associate for Central and Eastern European countries (Poland and Baltics)
What is Regulatory Affairs in the pharmaceutical industry?
It includes all the activities related to the regulation of pharmaceuticals, veterinary medicines, medical devices, biocides, agrochemicals, cosmetics and complementary medicines. This range of activities is very wide and has an impact on the whole lifecycle management of a product, from early stage development, through registration and marketing authorization granting, to post-authorization product maintenance and global expansion. Due to its central place, this domain is in interaction with all the disciplines of the pharmaceutical industry. The regulatory affairs professionals’ job is to ensure the compliance of products based on the legislation and requirements in all the regions where the company wants to distribute its products. They collect, collate and evaluate the scientific data their research and development colleagues are generating. They are responsible for the submission of registration documents to competent authorities, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned. They also provide strategic and technical advice, and keep track of the evolution of the regulation.
Examples of regulatory affairs areas: labelling, regulatory watch and strategy, CMC (Chemistry Manufacturing and Control), global/regional/local regulatory affairs, clinical regulatory affairs, registration, advertisement control, pricing and reimbursement, etc.
Travel to Japan. I am dreaming of such a trip since a really long time and it will be realized soon. Just few weeks to wait!
Philosophy of life:
“You have to trust in something – your gut, destiny, life, karma, whatever, because believing that the dots will connect down the road will give you the confidence to follow your heart, even when it leads you off the well-worn path. And that will make all the difference.” Steve Jobs Stanford University Speech 2005.
Best agap2 Memory:
Christmas Party in 2014 – I really enjoyed the walk in the snow and it was so nice to see how much we are in agap2.