Technical Project Management for Generic Drug Development

Description

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

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