Prashanth Kumar

  • Bengaluru Area, Karnataka, IN
  • 9550442864
  • prashanth.srirangam@gmail.com
Prashanth Kumar

Manager

SUMMARY

8 Years of Rich and Comprehensive experience in areas of Product development, IPR, Regulatory, Clinical research, staff training & management, and full responsibility for team leadership and motivation

WORK HISTORY

Work History
Oct 2015 - Present

Manager-Clinical Research

S3V Vascular Technologies, Bangalore

Accountable for all aspects of clinical studies, review and approve the study documents as per regulatory standards and Needs :

  1. Collaborate with Medical Directors, Marketing, Legal and Regulatory Affairs to design clinical programs
  2. Hire, train and oversee study Field Monitors and provide guidance on site issues
  3. Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to Management
  4. Responsible for the preparation of study budgets and timelines Monitor and track clinical trial progress and provide status update reports
  5. Responsible for  the selection of investigators and study sites
  6. Responsible for selection of CRO study staff and coordinating training including documentation
  7. Registration of Clinical studies with CTR(I) and Clinicaltrials.gov
  8. Contribute to the writing of clinical sections of Technical Dossier, IFU and IBs
  9. Verify and Approve the CER as per MEDDEV 2.7.1 Rev 03

Ongoing projects (National)- RENEIL SOUTH and RECAP Registry

Ongoing projects (International)- RENEIL INDONESIA 


Nov 2011 - Oct 2015

Senior Scientist/senior CRA

Relisys Medical Devices LTD

Manage project timelines, study budget and vendor performance to meet departmental and corporate goals

Partner with other research and development groups to achieve deliverables

Participate in clinical and department settings, including attending additional meetings and interact in a positive and professional manner

Lead in the planning of investigator meetings and making presentations for the Projects

Hire, train and oversee study Field Monitors, CTA'S and provide guidance on site issues

Interacts with Data Management, Biostatistics and Medical Writing contractors or personnel as needed to analyze and report clinical project data and support milestones

Co-Monitoring of regional sites for adherence to protocol and GCP as required

Faced Regulatory Audits (DCG(I) & CE Audits)

Assists in identifying clinical requirements for early-stage product pipeline evaluations (e.g., clinical utility considerations, estimates regarding design, costs, and timelines of clinical trials required for regulatory agency approval).
Participates on product development core teams as the clinical representative for assigned projects.

Projects Completed: Release-R1 Registry, ANANTH-1 PMS, CPR-CARE, CPR-Real, QCA Analysis of Corel+C, VEDA+R1 Registry, PTCA Registry and RR Multicenter Registry


Jul 2010 - Oct 2011

Scientist

Relisys Medical Devices LTD

Independently developed a New Drug Eluting Coronary stent(SES)

Working independently and proactively to coordinate all necessary activities required for setting up and monitoring a Clinical study

Assist in training and mentoring Junior CRA's

Patent drafting & Filling


Jan 2010 - Jun 2010

Assistant Professor

Browns College of Pharmacy

Taught Pharmacology to Graduates & Post Graduates

Taught Novel Drug Delivery systems to Post Graduates

Taught Regulatory affairs and IPR to Post Graduates


May 2007 - Jan 2008

FSO

Glenmark

Meeting the Physicians, chemists, stockiest to promote products.

Update doctors list on regular basis and regular follow ups of medical stores, retailers, pharmacies of hospitals.

Planning & Implementing new product/ promotional activities launch as per market strategy.

Ensuring implementation of policies & achieving target. 

EDUCATION

Education
2014 - 2017

PHD Doctorate

Gitam University
2012 - 2014

Diploma IN IPR

NALSAR University
2011 - 2012

PGDCAQM

HCU
2007 - 2010

M.Pharm (Pharmacology)

Kakatiya University
2002 - 2006

B.Pharmacy

Kakatiya University




CERTIFICATIONS

Certifications
2010 - Present

ICH/GCP

NIH, USA
2014 - Present

Risk Management 

DNV-GL

SKILLS

Skills

REGULATORY CLINICAL AFFAIRS

ICH/GCP

ISO 14155:2011

MDD 93/42/EEC

Risk management (ISO 14971) standards and CE Marking

ORGANISATION AND TIME MANAGEMENT

Ability to manage time effectively to prioritise activities and meet deadlines

CREATIVITY AND FLEXIBILITY, OPENNESS TO CHANGE

Ability to identify links between previously unconnected situations or problems

An openness to others’ ideas


ACHIEVEMENTS 

DSIR Recognition for In-House R&D (Feb 2016 )

5 New Products were Developed, commercialized and the Net sales of the products crossed 50 Crores (from 2010 to 2016)

5 Patents were filled (Indian)

New Clinical Research Department is set up in Relisys and now it is Handling 5+ National & International projects


COLLABORATIONS 

Pediatric Cardiology Department, Care Hospital, Hyderabad: Clinical Investigation of New generation Interventional Cardiology devices

National Aerospace Laboratory (NAL), Bangalore: Development of New class of Medical Devices


SCIENTIFIC PROFILE

Patents Owned- 01

No. of Research & Review Articles Published- 16

No. of Conference Presentations - 07