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PRESENT INDUSTRY EXPECTATIONS

FROM

PHARMACY STUDENTS & INSTITUTIONS

P. K. MitraManager-Marketing ServicesEurodrug Laboratories – India

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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

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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.

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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

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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

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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

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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

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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

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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 )

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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

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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

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INDUSTRY REGULATORY AFFAIRS: EXPECTATIONS

ACT AS :

1. Company outlet for Regulatory Agencies.

2. Regulatory interpreter of the company

3. Interface between Company & Regulatory

Agencies

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INDUSTRYREGULATORYAFFAIRS

Quality Control

Medical ServicesR&D

Manufacturing

Quality Assurance Marketing

INDUSTRY REGULATORY AFFAIRS: EXPECTATIONS

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INTELLECTUAL PROPERTY RIGHTS: EXPECTATIONS

Geographical Indication

Design

Integrated Circuits

Patents

Trade Secrets

Trade Marks

Copyright

PHARMACIST

Every Teacher or Student need to understand IPR

PG Diploma in patents law is offered by NALSAR

PHARMACY STUDENTS MUST BE THOROUGH IN

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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

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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

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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

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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

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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.

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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

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