Biotech Product Development and Commercialization
( 25 Modules )

Module #1
Introduction to Biotech Product Development
Overview of the biotech industry, product development process, and commercialization pathways

Module #2
Regulatory Framework for Biotech Products
Understanding FDA regulations, ICH guidelines, and EU directives for biotech products

Module #3
Biotech Product Development Process
Stages of product development, from discovery to commercial launch, including R&D, preclinical, and clinical trials

Module #4
Target Product Profile (TPP) and Product Requirements
Defining TPP, product requirements, and critical quality attributes

Module #5
Biotech Product Design and Development
Design controls, design verification, and design validation for biotech products

Module #6
Preclinical Development and Testing
In vitro and in vivo testing, pharmacology, and toxicology studies

Module #7
Clinical Trials:Planning and Execution
Protocol development, site selection, patient recruitment, and data management

Module #8
Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)
Regulatory requirements for clinical trials and manufacturing

Module #9
Biotech Product Manufacturing and Scale-Up
Process development, scale-up, and manufacturing of biotech products

Module #10
Quality Control and Assurance
Quality systems, testing, and release of biotech products

Module #11
Packaging and Labeling
Packaging design, labeling, and serialization for biotech products

Module #12
Biotech Product Supply Chain and Logistics
Supply chain management, distribution, and cold chain logistics

Module #13
Marketing Authorization and Approval
Submission of marketing authorization applications, dossier preparation, and approval processes

Module #14
Post-Marketing Surveillance and Pharmacovigilance
Monitoring and reporting of adverse events, signal detection, and risk management

Module #15
Commercialization Strategies for Biotech Products
Marketing, sales, and pricing strategies for biotech products

Module #16
Reimbursement and Access
Pricing, reimbursement, and access strategies for biotech products

Module #17
Biotech Product Launch and Market Entry
Launch planning, market entry strategies, and commercialization best practices

Module #18
Biotech Product Life Cycle Management
Product life cycle management, including post-launch monitoring and continuous improvement

Module #19
Compliance and Regulatory Affairs
Regulatory compliance, audits, and inspections for biotech companies

Module #20
Risk Management and Quality Systems
Risk management, quality systems, and continuous improvement for biotech companies

Module #21
Project Management for Biotech Product Development
Project management principles, tools, and best practices for biotech product development

Module #22
Biotech Product Development Team Management
Leading and managing cross-functional teams for biotech product development

Module #23
Communication and Stakeholder Management
Effective communication, stakeholder management, and crisis communication for biotech companies

Module #24
Financing and Funding for Biotech Start-Ups
Funding options, venture capital, and partnerships for biotech start-ups

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Biotech Product Development and Commercialization career

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Biotech Product Development and Commercialization ( 25 Modules )

Biotech Product Development and Commercialization
( 25 Modules )