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On:9910181655,
9015370577,
9027326396,
7011150644,     0120-4108608

Rapture Biotech is a bioservices company which provides services and training in Biotechnology, Bioinformatics, Industrial Microbiology, Plant Tissue culture, Computational Biology, Chemo-informatics, Agro-informatics
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PHARMACEUTICAL AND BIOPHARMACEUTICALINDUSTRIAL PROGRAM

OVERVIEW:

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

ELIGIBILITY:

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

EVALUATION:

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

JOB PROSPECTS:

The job opportunities are excellent in the areas of drug design and patenting, pharmacovigilance, regulatory affairs and quality operations in pharmaceutical, biotech, veterinary, cosmetic, food and medical devices, Contract Research Organisations and government. 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:

Select Distance Learning Program of your choice



Fill online application form & Pay fees



Confirmation of admission & enrollment number



Dispatch of Course material



Download & submit Assignment



Evaluation



Award of Certificate based on performance in Assignment

HOW TO APPLY:

Step 1 - Click on “Apply Online Form” from the website.

Step 2 - Completely fill application form and submit online.

Step 3- Submit application fee using NEFT from anywhere in India.

Bank Name: Kotak Mahindra Bank, Sector-18 Noida Name of the Account: Rapture Biotech International Pvt. Ltd. Account Number:2612431210 IFSC Code: KKBK0005033

OR

Submit fee usingDD/Cheques. Should be Drawn In favour of Rapture Biotech payable at Noida and send it to "Rapture Biotech, D-201, Sector 10 Noida - 201301, Uttar Pradesh" by Speed Post/Registered Post.

(For International Students): Bank to Bank Transfer by Swift Mode. Bank Name: Kotak Mahindra Bank,Sec-18, Noida
Name of the Account: Rapture Biotech International Pvt Ltd
Account Number:2612431210
Swift Code:KKBKINBB
IFSC Code:KKBK0005033

FOR FURTHER DETAILS AND ENQUIRIES:

Tel:0120- 4108608
Mobile: +91- 09910181655, 09027326396
E-mail:info@rapturebio.com, rapturebio@gmail.com

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