BINDU MANOHAR DONE

Boston's Northeastern University regulatory affairs master's student. As a Clinical Pharmacist intern at Manipal hospitals in India, she was trained in biopharmaceutical and medical device regulation, IND, NDA, Clinical Trial Applications, 21 CFR 210, 21 CFR 211, Quality Management Systems, ICH, CAPA, and Target Product Profiling (TPP). I'm seeking regulatory positions and new approaches to make healthcare more compliant.

• Pharmacovigilance, Ruver Technologies, 09/21 - 12/21, Implementing risk management strategies to minimize risks associated with medicines use, Communication of any risk to the public and HCPs
• Basic Life Support, Ramesh Hospitals, 11/17, The AHA Chain of Survival, specifically the BLS components, Important early use of an AED

1st Prize for App Presentation, 02/20, Awarded 1st prize by presenting an app titled For Better Life, whose main aim is to educate people about how there are so many low-cost, generic medicines available in the market that have the same therapeutic effect as branded ones.

Acharya Nagarjuna University - Guntur ,AP,INDIA: Observational Study of Drug Related Problems in Oncology, Acharya Nagarjuna University, 12/20 - 04/21, The objective of the study was to provide clinicians with data to improve patient care and therapeutic outcomes. The study evaluated drug-related problems in 151 subjects and found a total of 441 drug-related problems, including 148 drug interactions, 41 medication errors, and 252 adverse effects.

Northeastern University - Boston, MA, USA. Analysis of Sandoz's Omnitrope approval under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Omnitrope (Somatropin recombinant DNA origin) Injection, manufactured by Sandoz Inc., was given FDA approval on May 30, 2006. Preclinical safety data would have most likely been reported for biosimilars like Omnitrope are Pharmacodynamic Studies and Pharmacokinetic Studies.,