Area 1 *
Select
Virology and viral vaccines (HepB, HPV, Rota, etc.)
Bacteriology and bacterial vaccines (Pneumo, meningitis, pertussis, etc.)
Technologies: attenuation
Technologies: Inactivation
Technologies: conjugation
Technologies: recombinant
Technologies: combination vaccines
Technologies: formulation
Purity and potency assays
Stability assays/shelf life/accelerated degradation studies
Lot consistency
Randomization protocols and dose finding protocols
Endpoints and surrogates
Statistical analysis
Safety data collection
Clinical reports, clinical dossier, clinical trial report/audit
Process development: scale up validation, aseptic filling, formulation, labeling, packaging
Deviations/OOS/GAP analysis
Criticals systems: temperature control, humidity control, water systems, cold chain monitoring
Product documentation, testing, lot release
Personnel training and audits
Regulatory dossiers: filing/submission
WHO prequalification
Business development
International Distribution and Commercialization
International Market Access Strategies
Ad hoc project management/support for internal and externally-funded projects
Financial Support Identification (governmental and non-governmental agencies)
Grant Development, Application and Grants Writing
International Procurement and Tenders
International market access and Demand Forecast
International Accounting Methods and Reporting
Donors/Investors Development and Management
Proofreading/writing documents in English of grant applications, strategy plans, promotional literature etc.
Corporate Governance Structure and Management
International Code of Conduct: development and updates
Ethics of Marketing
Conflict of Interest: identification and management
Area 2
Select
Virology and viral vaccines (HepB, HPV, Rota, etc.)
Bacteriology and bacterial vaccines (Pneumo, meningitis, pertussis, etc.)
Technologies: attenuation
Technologies: Inactivation
Technologies: conjugation
Technologies: recombinant
Technologies: combination vaccines
Technologies: formulation
Purity and potency assays
Stability assays/shelf life/accelerated degradation studies
Lot consistency
Randomization protocols and dose finding protocols
Endpoints and surrogates
Statistical analysis
Safety data collection
Clinical reports, clinical dossier, clinical trial report/audit
Process development: scale up validation, aseptic filling, formulation, labeling, packaging
Deviations/OOS/GAP analysis
Criticals systems: temperature control, humidity control, water systems, cold chain monitoring
Product documentation, testing, lot release
Personnel training and audits
Regulatory dossiers: filing/submission
WHO prequalification
Business development
International Distribution and Commercialization
International Market Access Strategies
Ad hoc project management/support for internal and externally-funded projects
Financial Support Identification (governmental and non-governmental agencies)
Grant Development, Application and Grants Writing
International Procurement and Tenders
International market access and Demand Forecast
International Accounting Methods and Reporting
Donors/Investors Development and Management
Proofreading/writing documents in English of grant applications, strategy plans, promotional literature etc.
Corporate Governance Structure and Management
International Code of Conduct: development and updates
Ethics of Marketing
Conflict of Interest: identification and management
Area 3
Select
Virology and viral vaccines (HepB, HPV, Rota, etc.)
Bacteriology and bacterial vaccines (Pneumo, meningitis, pertussis, etc.)
Technologies: attenuation
Technologies: Inactivation
Technologies: conjugation
Technologies: recombinant
Technologies: combination vaccines
Technologies: formulation
Purity and potency assays
Stability assays/shelf life/accelerated degradation studies
Lot consistency
Randomization protocols and dose finding protocols
Endpoints and surrogates
Statistical analysis
Safety data collection
Clinical reports, clinical dossier, clinical trial report/audit
Process development: scale up validation, aseptic filling, formulation, labeling, packaging
Deviations/OOS/GAP analysis
Criticals systems: temperature control, humidity control, water systems, cold chain monitoring
Product documentation, testing, lot release
Personnel training and audits
Regulatory dossiers: filing/submission
WHO prequalification
Business development
International Distribution and Commercialization
International Market Access Strategies
Ad hoc project management/support for internal and externally-funded projects
Financial Support Identification (governmental and non-governmental agencies)
Grant Development, Application and Grants Writing
International Procurement and Tenders
International market access and Demand Forecast
International Accounting Methods and Reporting
Donors/Investors Development and Management
Proofreading/writing documents in English of grant applications, strategy plans, promotional literature etc.
Corporate Governance Structure and Management
International Code of Conduct: development and updates
Ethics of Marketing
Conflict of Interest: identification and management
Area 4
Select
Virology and viral vaccines (HepB, HPV, Rota, etc.)
Bacteriology and bacterial vaccines (Pneumo, meningitis, pertussis, etc.)
Technologies: attenuation
Technologies: Inactivation
Technologies: conjugation
Technologies: recombinant
Technologies: combination vaccines
Technologies: formulation
Purity and potency assays
Stability assays/shelf life/accelerated degradation studies
Lot consistency
Randomization protocols and dose finding protocols
Endpoints and surrogates
Statistical analysis
Safety data collection
Clinical reports, clinical dossier, clinical trial report/audit
Process development: scale up validation, aseptic filling, formulation, labeling, packaging
Deviations/OOS/GAP analysis
Criticals systems: temperature control, humidity control, water systems, cold chain monitoring
Product documentation, testing, lot release
Personnel training and audits
Regulatory dossiers: filing/submission
WHO prequalification
Business development
International Distribution and Commercialization
International Market Access Strategies
Ad hoc project management/support for internal and externally-funded projects
Financial Support Identification (governmental and non-governmental agencies)
Grant Development, Application and Grants Writing
International Procurement and Tenders
International market access and Demand Forecast
International Accounting Methods and Reporting
Donors/Investors Development and Management
Proofreading/writing documents in English of grant applications, strategy plans, promotional literature etc.
Corporate Governance Structure and Management
International Code of Conduct: development and updates
Ethics of Marketing
Conflict of Interest: identification and management
Area 5
Select
Virology and viral vaccines (HepB, HPV, Rota, etc.)
Bacteriology and bacterial vaccines (Pneumo, meningitis, pertussis, etc.)
Technologies: attenuation
Technologies: Inactivation
Technologies: conjugation
Technologies: recombinant
Technologies: combination vaccines
Technologies: formulation
Purity and potency assays
Stability assays/shelf life/accelerated degradation studies
Lot consistency
Randomization protocols and dose finding protocols
Endpoints and surrogates
Statistical analysis
Safety data collection
Clinical reports, clinical dossier, clinical trial report/audit
Process development: scale up validation, aseptic filling, formulation, labeling, packaging
Deviations/OOS/GAP analysis
Criticals systems: temperature control, humidity control, water systems, cold chain monitoring
Product documentation, testing, lot release
Personnel training and audits
Regulatory dossiers: filing/submission
WHO prequalification
Business development
International Distribution and Commercialization
International Market Access Strategies
Ad hoc project management/support for internal and externally-funded projects
Financial Support Identification (governmental and non-governmental agencies)
Grant Development, Application and Grants Writing
International Procurement and Tenders
International market access and Demand Forecast
International Accounting Methods and Reporting
Donors/Investors Development and Management
Proofreading/writing documents in English of grant applications, strategy plans, promotional literature etc.
Corporate Governance Structure and Management
International Code of Conduct: development and updates
Ethics of Marketing
Conflict of Interest: identification and management