Face the Emerging Deadly Diseases with the New Medicines - Medical Science Assignment Help

Assignment Task

The need to face the emerging deadly diseases with the new medicines complying with quality, safety and efficacy is utmost important, hence the necessity of regulatory compliance is essential to ensure the reliability of the medicine so the people will proceed to live healthy lives. (and increase trust on medicines among people)

The vision of this course to prepare students to deepen their knowledge regarding the industry specific regulatory process throughout the product life cycle blends well with my desires to study the regulatory procedure behind successful medicines and can get a solid platform through education provided by this course. I believe that a person's past experiences are the mirror to show a person's ability in what he can do in the future, so I would like to state my academic performance.

Strong interest in how medicines developed and how they treat diseases led me to enroll in the pharmacy, where I familiarized with the operation of the pharmaceutical industry. The knowledge regarding different regulatory agencies like FDA and how they ensure safety and efficacy of the new drugs, vaccines, medical devices right from the manufacturing to their marketing fascinates me to increase my knowledge in this area by joining a masters program in regulatory affairs in Northeastern university.

During my bachelor's studies, I was intrigued by books like pharmaceutical jurisprudence, forensic science which helped me a lot to know about the Drug and cosmetics act, good manufacturing practices and pharmacy act and what measures and laws to be followed while approving and marketing the drug by regulatory agencies and different schedules related to each category of drugs. Owing to my interest in drug design and development, and with good academic background helped me to get admission to M. Pharmacy in Pharmaceutical Chemistry in one of the eminent colleges affiliated by Pune University for local and international students. During my 6 months internship in the API department of Glenmark Pharmaceuticals, I learned how theoretical knowledge coordinates well with practical experience. For example, when we were analyzing a sample of API, we needed to follow cGMP practices and standard operating procedures to get the results within standard limits.

This gives me superficial ideas related to regulatory departments and how they play an important role to monitor the results to ensure quality,safety and efficacy. I also understood their role to study the patents and laws and guide the project team to make necessary changes to file new patents. The eagerness to get more familiar with the R&D department. I worked in the Microlab pharmaceutical company for one and half years as a research associate, where I individually carried out the analysis of finished products using analytical instruments. This experience amplified my analytical skills and leadership qualities.

I had exceptional exposure in the development and validation of analytical methods, and also learned how to imply cGMP and follow standard procedures. While carrying out development, I understood documentation of standard operating procedures and also what changes we need to do to differentiate the developed method from the existing patented method. With the help of the regulatory department we were able to solve the issues which may be faced during interpreting guidelines.I learned that hard work and perseverance are the key components to success.

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