Become a Technical Project Manager by Learning Generic Drug Development!
COURSE CONTENT
What you’ll learn
- Understand Project Management.
- Learn Generic Drug Development.
- Understand Desk Research for Generic Drug Development.
- Learn Raw Material Selection for Generic Drug Development.
- Learn Pre-Formulation Studies for Generic Drug Development.
- Understand Analytical Method Development Studies for Generic Drug Development.
- Discuss Formulation Studies for Generic Drug Development.
- Learn Pilot Manufacturing for Generic Drug Development.
- Understand Bioequivalency Study for Generic Drug Development.
- Learn Registration Dossier for Generic Drug Development.
Course Content
- Introduction –> 1 lecture • 9min.
- Introduction to Generic Drug Development –> 7 lectures • 58min.
- Introduction to Project Management –> 6 lectures • 34min.
- Project Management for Generic Drug Development –> 4 lectures • 12min.
- Desk Research for Generic Drug Development –> 8 lectures • 1hr 19min.
- Raw Material Selection for Generic Drug Development –> 5 lectures • 26min.
- Pre-Formulation Studies for Generic Drug Development –> 8 lectures • 21min.
- Analytical Method Development Studies for Generic Drug Development –> 9 lectures • 22min.
- Formulation Studies for Generic Drug Development –> 9 lectures • 36min.
- Analytical Studies for Generic Drug Development –> 1 lecture • 6min.
- Pilot Manufacturing for Generic Drug Development –> 1 lecture • 8min.
- Analysis of Pilot Batches for Generic Drug Development –> 1 lecture • 5min.
- Performing Bioequivalency Study for Generic Drug Development –> 1 lecture • 8min.
- Preparation Registration Dossier for Generic Drug Development –> 1 lecture • 4min.
- Conclusion –> 1 lecture • 8min.
Requirements
COURSE CONTENT
1 Introduction
2 Introduction to Generic Drug Development
2.1. Active Pharmaceutical Ingredient (API) & Finished Pharmaceutical Product (FPP)
2.2. Reference Listed Drug (RLD) & Generic (Multisource) Pharmaceutical Products
2.3. Pharmaceutical Bioequivalency (Therapeutic Equivalency)
2.4. Reference Listed Drug (RLD) Development
2.5. Generic Drug Development
2.6. Comparision of Reference Listed Drug (RLD) Development & Generic Drug Development
2.7. In-vitro & In-vivo Studies for Drug Product
3 Introduction to Project Management
3.1. Project & Elements of Project (Cost, Time, Scope)
3.2. Priorizitation of Project (Pipeline)
3.3. Project Phases
3.4. Project Manager
3.5. Project Team & Project Stakeholders
3.6. Project Management Tools
4 Project Management for Generic Drug Development
4.1. Project Diary for Generic Drug Development
4.2. Project Milestones for Generic Drug Development
4.3. Project Gantt Chart for Generic Drug Development
4.4. Generic Drug Development Project Phases (Execution Phase)
5 Desk Research for Generic Drug Development
5.1. Desk Research for Generic Drug Development
5.2. European Medicines Agency (EMA)
5.3. World Health Organization (WHO) & Food and Drug Administration (FDA)
5.4. Pharmacopoeias & Dailymed
5.5. Drugscom
5.6. DrugBank
5.7. Google Patents
5.8. Espacenet
6 Raw Material Selection for Generic Drug Development
6.1. Raw Material Selection for Generic Drug Development
6.2. Evaluation of Characteristics of API
6.3. Evaluation of Stability Characteristics of API
6.4. Evaluation of Suppliers of API
6.5. Evaluation of Inactive Ingredient and Packaging Material
7 Pre-Formulation Studies for Generic Drug Development
7.1. Pre-Formulation Studies for Generic Drug Development
7.2. Characterization of RLD
7.3. Defining Quality Target Product Profile (QTPP)
7.4. Evaluation of BE Requirements
7.5. Evaluation of Inactive Ingredient Required for Formula
7.6. Compatibility Study
7.7. Supplying New material / Apparatus / Equipment
7.8. Performing Pre-Formulation Trials
8 Analytical Method Development Studies for Generic Drug Development
8.1. Analytical Method Development Studies for Generic Drug Development-1
8.2. Analytical Method Development Studies for Generic Drug Development-2
8.3. Literature Search for Analytical Method Development
8.4. Supplying Chemicals / Materials / Equipments
8.5. Performing Method Development Studies
8.6. Determining Acceptance Criteria
8.7. Determining Dissolution Parameters
8.8. Performing Stress Studies
8.9. Performing Pre-Validation Studies
9 Formulation Studies for Generic Drug Development
9.1. Formulation Studies for Generic Drug Development
9.2. Performing Formulation Trials
9.3. Optimizing Formulation by using QBD
9.4. Supplying Chemicals / Raw-Materials / Equipments for Pilot Manufacturing
9.5. Preparing Formulations for Critical Material Attributes (CMA)
9.6. Preparing Formulations for Critical Quality Attribute (CQA)
9.7. Preparing Formulations for Critical Process Parameter (CPP)
9.8. Discriminitive Dissolution Parameters
9.9. Compatibility Study with Final Formula / Components
10 Analytical Studies for Generic Drug Development
10.1. Validation of Analytical Methods
10.2. Evaluation Bulk and Product Characteristic / Performance
10.3. Comparision Test Product with RLD In-vitro Conditions
10.4. Performing Analysis of Formulations for Critical Material Attributes (CMA)
10.5. Performing Analysis of Formulations for Critical Quality Attribute (CQA)
10.6. Performing Analysis of Formulations for Critical Process Parameter (CPP)
10.7. Performing Analysis of Formulations for for Discrimitive Dissolution Parameters
10.8. Performing Analysis of Formulations for Compatibility Study with Final Formula / Components
11 Pilot Manufacturing for Generic Drug Development
11.1. Evaluation of Chemicals / Raw-materials / Equipments used for Pilot Manufacturing
11.2. Performing Risk Assesment for Pilot Manufacturing
11.3. Performing Quality Procedures for Pilot Manufacturing
11.4. Documentation for Pilot Manufacturing
11.5. Manufacturing of Pilot Batches
12 Analysis of Pilot Batches for Generic Drug Development
12.1. Analysis of Chemicals / Raw-Materials used for Pilot Manufacturing
12.2. Analysis of Pilot Batches
12.3. Comparision Pilot Batches with RLD in In-vitro Conditions
12.4. Determining of BE Batches
13 Performing Bioequivalency Study for Generic Drug Development
13.1. Preparing Documentation for In-vitro Test Results
13.2. Preparation of Samples for BE Studies
13.3. Performing BE Studies
13.4. Documentating of BE Results
14 Preparation Registration Dossier for Generic Drug Development
14.1. Preparation of Registration Dossier
14.2. Performing of Registration Application
15 Conclusion