This document discusses the role of Pharm Ds in improving the pharmaceutical industry. It begins with an introduction to the Pharm D degree, which is a six-year program in India involving courses in various medical and scientific fields. The document then outlines several roles Pharm Ds can have, including in regulatory affairs, site management, formulation, price fixing, and marketing. It provides details on the responsibilities in regulatory affairs, formulation research, pharmacokinetics research, and considerations around drug price and pharmacoeconomics. Finally, it lists some positions in the pharmaceutical industry suited for Pharm Ds.

1. Pharm D role
in improving
Pharma
Industries
Venture
By;
Dr. K. ARUNRAJ, Pharm.D.

2. Introduction to Pharm D
➢ Pharm D is short form of “Doctor of Pharmacy.” It is the professional
Pharmacy doctoral program. In India, it is a total six years program after
10+2
➢The academic study includes one year of Anatomy & physiology, Micro
biology, Chemistry, formulation, med-chemistry, Pharma-cognosy,
Hospital Pharmacy, Community Pharmacy, Clinical Pharmacy,
Biostatistics and Research Methodology, Clinical Toxicology, Clinical
Research, Pharmacoepidemiology, Pharmacoeconomics, Clinical
Pharmacokinetics and Pharmacotherapeutic Drug Monitoring and two
years of Pharmacology, Three years of Pharmacotherapeutics and
Pathophysiology.
Ref- NCBI (National Center for Biotechnology Information, U.S. National
Library of Medicine )

3. CONTENTS
1. Regulatory affairs
2. Site Management
3. Formulation
4. Price Fixing
5. Marketing

4. Regulatory Affairs:
• The regulatory affairs oversees how drugs, and
medical products are developed, tested, manufactured,
marketed, and distributed to certify that they meet
regulatory standards for human use.
• Regulatory affairs professionals are responsible for
ensuring manufacturers’ compliance with applicable
global legislative and regulatory requirements at each
stage of product development. In the drug, medical
device, and biologic product industries, these phases
include: research and development, clinical trials,
regulatory submissions, manufacturing, marketing,
distribution, reimbursement, and post-market
surveillance.
Pre clinical
and clinical
trails
Marketing
and post-
marketing
Manufactu
ring
Licensing
Ref- WORKING IN
REGULATORY AFFAIRS:
CAREERS AND TRENDS
By Shayna Joubert | January 3,
2018

5. Add-on Values
Site
Management /
Supervisor
Clinical
trails
R and
D
Manufactur
ing
Formulation /
Brand
Management
Lead
Compoun
d Analysis
Inventory /
procuring,
transporting
, of
chemicals
Formulati
on
Research

6. Add-On Value
Pharmacokin
etics/Dynami
cs Research
Dosing /
Formulat
ion study
Bio-
availabili
ty and
equality
study
ADME
study
Bio-
similars
Study

7. Drug price and Pharmacoeconomics
1. Pharmacoeconomics is vitally important to drug manufacturers in terms
of communicating to external decision-makers (payers, prescribers,
patients) the value of their products, achieving regulatory and
reimbursement approval and contributing to commercial success.
2. Since development of new drugs is long, costly and risky.
3. The use of pharmacoeconomics in early development phases is likely to
enhance the efficiency of R&D resource use and also provide a solid
foundation for communicating product value to external decision-
makers further downstream, increasing the likelihood of regulatory
(reimbursement) approval and commercial success.
Ref-Springers Link

8. MARKETING
Marketing
Online and
Offline
promotion
activities
Market research
and Prescription
audit
Post-marketing
surveillance
1 ADR’s
2 Effect
3 feed back
Education /
Training for
stakeholders
Effective brand
communication
with Dr’s
Liaison
between R&D
and Marketing
team

9. POSITIONS ;
Regulatory Affairs
clinical research associate
Pharmacoeconamic scientist
Pharmacokinetic scientist
Medico marketing
Medical Affairs
Product manager

10. THANKING YOU