Present industry expectations from pharmacy students

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Present industry expectations from pharmacy students

  1. 1. 1 PRESENT INDUSTRY EXPECTATIONS FROM PHARMACY STUDENTS & INSTITUTIONS P. K. Mitra Manager-Marketing Services Eurodrug Laboratories – India
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  12. 12. 1 INDUSTRY REGULATORY AFFAIRS: EXPECTATIONS ACT AS : 1. Company outlet for Regulatory Agencies. 2. Regulatory interpreter of the company 3. Interface between Company & Regulatory Agencies
  13. 13. 1 INDUSTRY REGULATORY AFFAIRS Quality Control Medical ServicesR&D Manufacturing Quality Assurance Marketing INDUSTRY REGULATORY AFFAIRS: EXPECTATIONS
  14. 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. 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. 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. 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. 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. 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. 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
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