Pharma And Biopharma

PHARMA AND BIOPHARMA PHARMACEUTICAL AND BIO PHARMA CEUTICAL INDUSTRIAL PROGRAM

 

This programme aims to make the candidates learn about the terminologies used in pharmaceutical and biopharmaceutical industries as well as let them know the differences between the two sectors. According to a report by McKinsey Global Institute, healthcare sector in India grew from 4% of average household income in 1995 to 7% in 2005, and is expected to grow to 13% by 2025. According to the same report, if the Indian economy continues on its current high growth path, then the Indian pharmaceuticals market will undergo a major change in the next decade. It is expected that the market will triple to US$ 20 billion by 2015 and can easily become one of the world’s top-10 pharmaceuticals markets.The Indian pharmaceutical industry is also getting increasingly U.S. FDA compliant to harness the growth opportunities in areas of contract manufacturing and research.

Indian companies such as Ranbaxy, Sun Pharma, and Dr. Reddy’s are increasingly focusing on tapping the U.S. generic market. There are many multinational pharmaceutical companies who are looking forward to India as an attractive destination for Research & Development, contract manufacturing, clinical trials conduct and generic drug research

Top markets for pharmaceutical products continue to be developed countries in Western Europe, East Asia, and North America with high per capita spending on healthcare, growing elderly populations, and advanced regulatory systems.

PROGRAMS NAME:
1.   Advance Certificate Program in Biopharma IT/IS compliance and Qualifications (PB-01)
  • Module 1: Introduction to Compliance
  • Module 2: Infrastructure Qualification
  • Module 3: Meeting legal obligations
  • Module 4: Role of regulations and guidelines
Minimum duration: 3 months & Maximum duration: 6 months
2.   Regulations for Biologics and Pharmaceutical Product (PB-02)
  • Module 1:Introduction to Regulatory Affairs
  • Module 2:International Licensing and Drug Regulatory Affairs
  • Module 3:Regulatory Documentation for Biologics /Medical Diagnostics andPharmaceutics
  • Module 4: Global Regulatory Compliance Systems
Minimum duration: 3 months & Maximum duration: 6 months
3.   Advance Certificate Program in Validation Systems (PB-03)
  • Module 1: Validation: Principles/International Regulations
  • Module 2: Validation master plans (VMP) and Documentation
  • Module 3: Commissioning and Installation Qualification
  • Module 4: Operational/Performance Qualification Protocols (OP and QP)
Minimum duration: 3 months & Maximum duration: 6 months
4.   Advance Certificate Program in Active Pharmaceutical Ingredient (API) & Drug Product Specifications– From Clinical Development to Market Approval (PB-04)
  • Module 1: Fundamentals of APIs
  • Module 2: GMP for Manufacturers of Active Pharmaceutical Ingredients
  • Module 3: Quality by Design (QbD)
  • Module 4: Quality Risk Management (QRM)
  • Module 5: Pharmaceutical Quality System (PQS)
Minimum duration: 3 months & Maximum duration: 6 months
5.   Advance Certificate Program in Introduction to Pharma, Biopharma and Its Applications (PB-05)
  • Module 1: Introduction to Pharmacology
  • Module 2:Introduction to Biopharmaceuticals
  • Module3:Comparative Drug Development from biologics versus small molecules
  • Module 4:Biotechnology Industry Perspective on Drug Development
  • Module 5: Applications of Biotechnology in Drug Discovery and Methods of Production
  • Module 6:Pharmacology, Toxicology, Therapeutic Dosage Formulations, and Clinical Response
Minimum duration: 3 months & Maximum duration: 6 months
6.   Advance Certificate Program in Preclinical Evaluation and Future Prospects of Biopharmaceuticals (PB-06)
  • Module 1: Biopharmaceuticals: Definition and Regulation
  • Module 2: The Principles of ICH S6
  • Module 3:Implementation of ICH S6: EU Perspective
  • Module 4:Implementation of ICH S6: Japanese Perspective
  • Module 5:Implementation of ICH S6: US Perspective
  • Module 6:Demonstration of Comparability of a Licensed Product after a Manufacturing Change
  • Module 7:Future Prospects
Minimum duration: 3 months & Maximum duration: 6 months
7.   Advance Certificate Program in Pharmaceutical Product Management (PB-07)

  • Module 1: Pharmaceutical Industry

  • Module 2: Understanding of pharmaceutical marketing
  • Module 3:Practical aspects of pharmaceutical brand management
  • Module 4:Development of marketing plan
  • Module 5:Branding
  • Module 6: Product concept and pricing in pharma industry
  • Module 7:Marketing strategies
Minimum duration: 3 months & Maximum duration: 6 months
8.   Diploma Certificate Program in Pharmaceutical Marketing (PB-08)
  • Module 1- Introduction to Pharmaceutics
  • Module 2- Pharma Product Management
  • Module 3- Pharmaceutical Marketing, logistics and Management
  • Module 4- Human Resource Management
  • Module 5- Drug Design and Discovery
  • Module 6- Emerging Areas of Pharma Industry: Clinical Trials and Contract Research
  • Module 7- Pharma Practices, IPR and Procedures
  • Module 8- Business Research Methodology
Minimum duration: 3 months & Maximum duration: 6 months
9.   Diploma Certificate Program in Biopharmaceutical sciences and Industrial Applications (PB-09)
  • Module 1: Fundamentals of Biopharmaceutical sciences
  • Module 2:Pharmacology
  • Module 3:Pharmaceutics
  • Module 4:Pharmacognosy
  • Module 5: Fermentation and cell culture processing
  • Module 6:Protein purification processing
  • Module 7: Cost Effectiveness of Medicines (Pharmacoeconomics)
  • Module 8:Regulatory Affairs
Minimum duration: 3 months & Maximum duration: 6 months
10.   Diploma Certificate Program in Vaccine Production (PB-10)
  • Module 1: Fundamentals of vaccines and vaccination
  • Module 2: Types of vaccines
  • Module 3: How are vaccines produced
  • Module 4: General considerations in Vaccine production
  • Module 5: Vaccines by Recombinant DNA technology
  • Module 6: Role of Vaccination in antimicrobial resistance
  • Module 7: EU regulatory framework for vaccines
  • Module 8: Global Action Plan for Influenza Vaccines (GAP)
Minimum duration: 3 months & Maximum duration: 6 months
11.   Diploma Certificate Program in Pharma Quality Control, Assurance and Regulatory Affairs (PB-11)

  • Module 1: GMP of Pharmaceutical manufacturing

  • Module 2: Packaging of Dosage Forms and documentation
  • Module 3: An introduction to laws with regard to drug product design, manufacture and distribution in India
  • Module 4: Good Laboratory Practices (GLP)
  • Module 5: Good Clinical Practices (GCP)
  • Module 6: International Regulatory Requirements Theory
  • Module 7:Regulatory requirements for product approvals
  • Module 8: FDA Approvable indications and other considerations
  • Module 9: Nonclinical drug development
  • Module 10: Quality Improvement Techniques in Drug Manufacturing Theory
Minimum duration: 3 months & Maximum duration: 6 months
12.   Diploma Certificate Program in Drug Regulatory Affairs (PB-12)
  • Module 1:Drug regulation fundamentals
  • Module 2:ISO and ISO audits
  • Module 3:Intellectual Property Rights
  • Module 4:Stability testing of API and finished pharmaceutical products
  • Module 5:Packaging development
  • Module 6:ASEAN drug regulatory affairs
  • Module 7:Drug regulation in India- CDSCO
  • Module 8:Drug regulation in USA
  • Module 9:Drug registration in GCC countries
  • Module 10:Drug registration in European countries
Minimum duration: 3 months & Maximum duration: 6 months
Program Code Indian Candidates International Candidates
Online Mode Weekend Classroom Online mode only
PB-01 Rs. 8000 Rs. 20000 US $ 300
PB-02 Rs. 8000 Rs. 20000 US $ 300
PB-03 Rs. 8000 Rs. 20000 US $ 300
PB-04 Rs. 10000 Rs. 20000 US $ 350
PB-05 Rs. 15000 Rs. 20000 US $ 500
PB-06 Rs. 17000 Rs. 25000 US $ 550
PB-07 Rs. 17000 Rs. 25000 US $ 550
PB-08 Rs. 20000 Rs. 25000 US $ 650
PB-09 Rs. 20000 Rs. 25000 US $ 650
PB-10 Rs. 20000 Rs. 25000 US $ 650
PB-11 Rs. 30000 Rs. 35000 US $ 950
PB-12 Rs. 30000 Rs. 35000 US $ 950

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ELIGIBILITY:

Persons pursuing or passed out of M.B.B.S/BDS/B.Sc./M.Sc./B.Tech/M.Tech/Ph.D in Biotechnology, Bioinformatics, Microbiology & other relevant Qualification in the respective areas are eligible.

EVALUATION:

At the end of the duration of a program, students go through a well-defined evaluation. Grades are given according to their performance in Assignment and then certificate is awarded.

JOB PROSPECTS:

Clinical Research and Healthcare program clear your all key concepts of clinical data management and give you a broad understanding of the role played by Clinical Rearch departments. A clinical data research associate or clinical data manager can work for various organizations in healthcare and pharmaceuticals. Companies hiring such professionals are pharmaceutical companies, biotechnology organizations, academic medical centers, hospitals, and government departments. There are wide openings in hospitals, healthcare centers and government institutions. Leading hospitals like escorts, Max healthcare, Fortis, Apollo, Artimis and Pharma companies engage healthcare management and clinical research students at various positions. Basically it is designed to highlight the candidate’s commitment to continual professional development and will ensure a competitive edge when applying for future employment positions. These professionals will find employment as:

  • Pharmacovigilance Manager
  • Drug Safety Specialist
  • Project Assistant
  • QA/QC executive
  • Project Manager
  • Clinical laboratory technician
  • Crime scene technician
  • Forensic Chemist
  • Biotechnology Consultant and MANY MORE…
EVALUATION & AWARD OF CERTIFICATE:
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