Medical Project

Maulik Suchde

** ******** ****** ***# **, Boston, MA- 02115 |331-***-**** | **************@*****.***

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EDUCATION:

• Northeastern University, Boston, USA

Masters of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices August 2012

GPA: 3.88/4.0

• Bombay College of Pharmacy, University of Mumbai, India

Bachelor of Pharmacy; GPA: 3.77/4.0 May 2011

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PROJECTS

• Investigational New Drug Application (IND)

Drafted an IND application for a hypothetical drug based on the FDA’s Guidance, Code of Federal Regulations, ICH’s Guidance and eCTD Format.

• Patent Law in India and its Market Implications: A Closer Look at Section 3(d)

A discussion about patent evergreening with reference to the Glivec case in India.

• Structured Abstract

The writing and formatting of a clinical trial according to the requirements in various journals.

• Informed Consent

The preparation of an informed consent document based on clinical trial data provided and a power point presentation on the same trial aimed at potential participants.

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EXPERIENCE:

Summer Internship at Sun Pharmaceutical Industries Ltd, Mumbai, India June 2010 - July 2010

• Designed Project Initiation Forms by tabulating data from FDA’s Orange Book.

• Conducted a search for Indian patents corresponding to a US patent.

• Reviewed Prosecution and Litigation History.

Member of Intellectual Property Society at Northeastern School of Law September 2011 - Present

• Attended various seminars to further understand the field of IP.

Industrial Visit

Pfizer Pharmaceuticals -Veterinary Medical Pharmaceutical Sciences Division June 2011

• Observed the working of the Formulation and Chemical R&D Department.

Member of Editorial Committee June 2010 – May 2011

Indian Pharmaceutical Association Students’ Forum

• Was responsible for two magazines: a monthly e-magazine ‘Panache Live’ and an annual magazine ‘Panache.’ (Panache is a national level pharmacy magazine for students)

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EXTRA-CURRICULAR ACTIVITIES:

• Successfully completed three levels of French with Alliance Française de Bombay

• Cleared Grade 2 and Grade 3 of the Communication Skills Examination conducted by Trinity College.

• Participated in the Pharmacy Promotion Rally for the promotion of the role of a pharmacist in society at the National Pharmacy Week at Mumbai, India.

I am a permanent resident and am authorized to work in the United States.

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