Darshan Kulkarni

The One Stop Drug Expert

Darshan Kulkarni

FDA Regulatory Attorney

Darshan can speak to multiple facets of drug and device development and the issues that may arise. He is the Principal Attorney at the Kulkarni Law Firm and focuses his practice on handling the needs of FDA regulated companies including drug makers, device makers, food manufacturers, cosmetics companies and various healthcare providers like physicians and pharmacists.

Darshan Kulkarni

Pharmacist

Darshan can speak to multiple facets of drug and device development and the issues that may arise. He is the Principal Attorney at the Kulkarni Law Firm and focuses his practice on handling the needs of FDA regulated companies including drug makers, device makers, food manufacturers, cosmetics companies and various healthcare providers like physicians and pharmacists.

Darshan Kulkarni

Educator

Darshan is able to communicate in a manner that is understandable to people in all walks of life. While he can speak to clinicians due to his Doctorate in Pharmacy, he has taught children as young as 6 to over 60 with little to no science background. He has over 20 years experience teaching courses ranging from pharmacology and toxicology at the Johns Hopkins CTY/CAA Program for talented youth as a 20 year old, to teaching in Thomas Jefferson University Medical School, Temple University Law School, Drexel School of Engineering, Temple School of Pharmacy, University of Florida School of Phamacy, Grand Rounds at Vanderbilt, and the MBA Program at the University of the Sciences. He is current Visiting Professor at the University of the Science’s Biomedical Writing Program, and has won awards for his teaching and use of technology.

Communicating Non FDA-Approved Information

Feb 25 – Mar 1, 2018 @ Exhibitor Live

CLE/CE program on "The Law, Ethics and practical information for Creating and Marketing a Compounding Pharmacy"

November 11, 2017 @ University of the Sciences, Medical Writing

 

Cannabis Laws

October 22, 2017 @ University of the Sciences, Cannabis Event

Going Beyond the FDA Approved Label - Stepping where Angels fear to Tread

Aug 19, 2017 @ REEP

How to create a War Room when the FDA walks through the door

Aug 15, 2017  Clinical Research Symposium

FDA Inspections: Handling the Consequences

May 22, 2017 @ MAGI East

The 21st Century Cures Act

May 21, 2017 @ MAGI East

State Research Laws and Regulations

May 21, 2017 @ MAGI East

Healthcare Fraud - Investigations and Review

April 26 22, 2017 @ Jenkins

Life Cycle Management for IISR Research

February 15, 2017 @ CBI’s Research Summit

Responding to Compounding Pharmacy Inspections

January 25, 2017 @ FDANews

The Basics of Clinical Trial Research: Differing Perspectives of Sponsors, Sites and Investigators

November 2016 @ABA Webinar

Panel Discussion: Effectively Preparing for an FDA Sponsor Investigation

October 27, 2016 @ 4th Annual Innovations In Clinical Data Management Conference

Responding to an FDA Clinical Trial Site Inspection

October 27, 2016 @ 4th Annual Innovations In Clinical Data Management Conference

Responding to an FDA Warning Letter

October 12, 2016 @ PSHP Annual Meeting

Improve CMS Guidance and a Move Toward Centralization

June 15, 2016 @ ExL Pharma

Techniques to Maintain Transparency Throughout the Establishment of Fair Market Value for Advisory Boards Panel Session

June 15, 2016 @ ExL Pharma

Macro trends affecting medical affairs, MSLs & Medical writers

April 13, 2016 @ ExL Pharma MASS

Organizational Interpretation of Informed Consent Forms (ICF) (Panel)

April 13, 2016 @ ExL Pharma MASS

Collaborative strategies between legal and Medical Affairs for Press Releases

April 13, 2016 @ ExL Pharma MASS

Streamline Operations for Compliant Contact Center Communications (Panel)

April 13, 2016 @ ExL Pharma MASS

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