The document discusses expectations from pharmacy students and institutions by the pharmaceutical industry. It notes that current graduates lack practical skills and awareness of industry trends. It calls for periodic updates to pharmacy curricula to reflect rapid changes in the industry's focus, direction, and functioning. The expectations of key industry departments like R&D, clinical research, quality assurance, and regulatory affairs are outlined. These include training students in areas like drug development, clinical trials, quality control, and regulatory guidelines. The document recommends reforms to teaching methods and greater industry exposure for faculty and students through workshops, training, and consultancy to bridge gaps between education and industry needs.
2. 1
CURRENT INDUSTRY OPINION
Present Pharmacy Graduates / Post Graduates are:
Under Equipped : Practical Knowledge, Technical Skills
Lack Exposure on : Latest Developments in Pharma Industry
Intellectual Property Rights
Industry Based Regulatory Needs
Unaware About : Trends in New Drug Pipelines
Latest Drugs Introduced in the Globe
R & D Costs and Returns for New Drugs
3. 1
CURRENT PHARMACY CURRICULUM
IS THERE ANY NEED TO CHANGE - YES
Periodical change in curriculum was the concept yester years.
Since Pharma Industry has under gone a rapid change in:
Focus
Direction
Functioning
There is a need to update the curriculum from time to time
It should be a continuous process and be need based.
4. 1
EXPECTATIONS OF VARIOUS DEPARTMENTS
1. API - R & D
2. Formulation – R & D
3. Clinical Research
4. Analytical
5. Quality Assurance
6. Industry Regulatory Affairs
7. Intellectual Property
8. Soft Skill Development
5. 1
API - R & D DEPARTMENT: EXPECTATIONS
ACQUAINT THE PHARMACY STUDENTS ON:
• Synthetic Chemistry including Multi-Step Synthesis
• Modern Chromatography
• Spectroscopic Techniques
• Library Design & Diversity Analysis
• Pharmacopoeia Elucidation
• Quantitative Structure-Activity Relationship
• Applications of Modern NMR Techniques
6. 1
FORMULATION R & D : EXPECTATION
ACQUAINT THE PHARMACY STUDENTS ON:
• Discovery Research
• Novel Drug Delivery Systems
• New Formulation Development
• Stability Studies & Bio-Equivalence Study
• Quality Management
• Regulatory Management
• Disease Management & Therapy Basket
7. 1
CLINICAL RESEARCH: EXPECTATIONS
ACQUAINT THE PHARMACY STUDENTS ON:
1. Details of Phase I, II , III , IV Studies & GCP Guidelines
2. Preparation & Execution of Study Protocols, CRF & ICF
3. Designing, Conducting & Analysis of Clinical Research
4. Monitoring of Studies, Review & Reporting Safety Data
5. Evaluation of Toxicity Studies, BE & PMS Studies
6. Maintenance of Source Documents & Report Publishing
8. 1
ANALYTICAL DEPT : EXPECTATIONS
ACQUAINT THE PHARMACY STUDENTS ON:
1. Method Development For NCE, NDA & ANDA
2. Method Analysis For Scale Up Techniques
3. Method Validations For Product Quality
( Assay, Related Substances, Residual Solvents )
4. Calibration & Maintenance of Laboratory Instruments &
Records / Documents complying with GMP
5. Knowledge & Implications of GLP
9. 1
QUALITY ASSURANCE: EXPECTATIONS
TRAIN THE PHARMACY STUDENTS ON:
• Regulatory Requirements
( cGMP, WHO GMP, MCA,TGA, US FDA )
• Validation
( Prospective ,Concurrent, Retrospective, Revalidation )
• Batch Manufacturing & Packing Records
• SOP, STP, Specifications & Documentation
• Validation and Calibration of QC Equipment:
( HPLC, GC,TLC, Titrametric Analytical methods, UV, IR
Spectrophotometer, pH Meters, Dissolution & Disintegration
apparatus etc )
10. 1
QUALITY ASSURANCE: EXPECTATIONS
….. Contd
• Validation Protocol and Reports
• Stability Protocol and Reports
• Maintenance & Ensurance of :
On line checking, Deviation Handling
• Effective Handling of Market Complaints
• Audit :
a) Internal audit b) External audit
11. 1
INDUSTRY REGULATORY AFFAIRS:
EXPECTATIONS
ACQUIANT THE PHARMACY STUDENTS ON
Technical Knowledge of Regulatory Requirements
(Technology Transfer, Validation, Documentation, cGMP ,
Patents, Basics of Pharmaceutical Formulations & NDDS.)
FOR:
• Regulated Countries
• Semi-regulated Countries
• Non-Regulated Countries
• Knowledge of Pharma developments country wise
• Knowledge of GMP Guidelines of each country
14. 1
INTELLECTUAL PROPERTY RIGHTS:
EXPECTATIONS
Geographical Indication
Design
Integrated Circuits
Patents
Trade Secrets
Trade Marks
Copyright
P
H
A
R
M
A
C
I
S
T
Every Teacher or Student need to understand IPR
PG Diploma in patents law is offered by NALSAR
PHARMACY STUDENTS MUST BE THOROUGH IN
15. 1
SOFT SKILL DEVELOPMENT
ENABLE THE PHARMACY STUDENTS ON :
1. Personality Development & Positive Attitude
2. Communication Skills & Shop Floor Relations
3. Command over English Language
4. Commitment
5. Sincerity & Dedication
6. Ownership Feeling
7. Effective Planning
16. 1
ADVISE TO FACULTY
Introduce Reforms in:
• Teaching Methodology
• Pedagogy
• Methods of Evaluation.
• Training of the Faculty on Latest technologies
• Industrial Training
• Effective & Meaningful Projects & Workshops
17. 1
ADVISE TO FACULTY ….. Contd
Acquire awareness about advances in
pharmaceutical industry and R&D through :
• Workshops
• Seminars
• Guests Lectures
• Visits to the Industry
The aforesaid lacunae which are to be Rectified For
Effective Pharma Education
18. 1
It is in this area we have to concentrate and make an impact on
value proposition.
Hence it is proposed to bring in certain evaluation methods where
in they have to be computed for awarding the degree.
To name a few :
1. Report writing after a industry Training / Visit.
2. Objective tests after a Guest Lecture / Seminar / Workshop
3. Project work in Community Pharmacy / Hospital.
Preparation of working models or fabrications need to
be made as evaluation components in awarding degrees
GOOD PHARMACY EDUCATIONAL PRACTICES
19. 1
GOOD PHARMACY EDUCATIONAL PRACTICES … Contd
To bring legislation for :
• Offering Training to the Students and Staff of the Institutions
by the Industry.
• The Institution to provide Consultancy services to the
Industry.
• Consequent upon implementing these recommendations:
• The institutions will provide the technical man power of
highest order & become centers for consultancy for the
Pharma industry.
20. 1
JUST REMEMBER
NOTHING IS EVER A THREAT
IT IS ALWAYS AN
OPPORTUNITY
IT IS WE WHO CONVERT
OPPORTUNITIES INTO
THREATS
AND THREATS INTO GREAT
OPPORTUNITIES
