The document outlines the World Health Organization's guidelines for technology development and transfer, emphasizing the importance of equitable access to healthcare technologies and outlining key protocols for effective implementation. It discusses essential aspects such as risk management, regulatory standards, commercialization strategies, and the role of various agencies in facilitating successful technology transfer. The conclusion highlights the need for collaboration among stakeholders to leverage technology for improved health outcomes globally.

1. Technology Development
and Transfer: WHO
Guidelines
This presentation explores the World Health Organization's (WHO)
comprehensive guidelines for technology transfer, essential for fostering
innovation and equitable access to healthcare technologies worldwide.
The presentation will cover the intricacies of technology transfer
protocols, quality risk management, and other critical aspects crucial for
successful implementation.
RM
by Raj Kumar Mandal

2. WHO's Role in Technology Transfer
Fostering Innovation
WHO actively promotes research and
development (R&D) of essential health
technologies through collaborative
initiatives and funding opportunities.
Ensuring Equitable Access
WHO works to ensure that
technologies developed through these
efforts are accessible to all, regardless
of geographic location or economic
status.
Setting Standards
WHO develops and disseminates
guidelines and standards for
technology transfer, ensuring quality,
safety, and efficacy of transferred
technologies.

3. Understanding Key Terminologies
Technology
Refers to knowledge, processes, and
tools used to create or improve
products, services, or systems.
Transfer
Involves the sharing of technology
between different entities, typically
from a source to a recipient.
Licensing
Grants permission to use intellectual
property rights, such as patents or
trademarks, for a specified purpose
and duration.

4. Technology Transfer Protocols
1
Needs Assessment
Understanding the recipient's needs, infrastructure, and
capacity to implement the technology.
2 Technology Selection
Choosing appropriate technologies based on
effectiveness, feasibility, and affordability.
3
Negotiation and Agreement
Establishing clear terms of technology transfer, including
licensing, intellectual property, and support.
4 Implementation and Training
Transferring knowledge and skills, providing technical
support, and ensuring effective integration of the
technology.
5
Monitoring and Evaluation
Assessing the impact and effectiveness of the
technology transfer process to identify areas for
improvement.

5. Quality Risk Management in Technology Transfer
1
Risk Identification
Proactive identification of potential hazards and vulnerabilities related to the transfer process.
2
Risk Assessment
Evaluating the likelihood and impact of identified risks to prioritize mitigation efforts.
3
Risk Control
Implementing measures to minimize or eliminate identified risks through
preventive actions or contingency plans.
4
Risk Monitoring and Review
Continuously monitoring and assessing the effectiveness of risk
controls and making adjustments as needed.

6. Transferring Technology from R&D to Production
1
Process Transfer
Scaling up the production process from laboratory to pilot and then to full-scale manufacturing,
ensuring consistency and quality.
2
Packaging Transfer
Adapting packaging materials and methods to the new production environment,
maintaining sterility, stability, and labeling requirements.
3
Cleaning Validation
Implementing robust cleaning procedures and validating
their effectiveness to prevent cross-contamination and
ensure product safety.

7. Granularity of Technology Transfer Process
API Transfer
Transferring the knowledge
and processes for
manufacturing the active
pharmaceutical ingredient.
Excipient Transfer
Transferring the knowledge
and processes for
manufacturing inactive
ingredients (excipients) used
in the formulation.
Finished Product
Transfer
Transferring the knowledge
and processes for assembling
and packaging the final
product.
Packaging Material
Transfer
Transferring the knowledge
and processes for sourcing
and using packaging
materials for the final
product.

8. Documentation, Premises, and
Equipments
1
Documentation
Comprehensive documentation, including
protocols, procedures, and training
materials, is essential for successful
technology transfer.
2
Premises
Adequate infrastructure, including
laboratories, production facilities, and
storage areas, is crucial for implementing
the technology.
3
Equipment
Appropriate equipment, calibrated and
validated, is necessary for manufacturing
and quality control of the transferred
technology.

9. Qualification and Validation, Quality Control, Analytical Method
Transfer
Qualification and Validation
Ensuring that equipment, facilities, and processes meet predetermined standards and perform as intended.
Quality Control
Implementing rigorous testing procedures and monitoring throughout the production process to ensure consistent quality.
Analytical Method Transfer
Ensuring that analytical methods used for quality control are transferred and validated for the new production environment.

10. Approved Regulatory Bodies and Agencies
FDA (U.S. Food and
Drug
Administration)
Sets standards for food
safety, drug efficacy, and
medical devices, ensuring
the safety and effectiveness
of products.
EMA (European
Medicines Agency)
Regulates the
development,
manufacturing, and
marketing of medicinal
products in the EU,
ensuring quality, safety,
and efficacy.
WHO (World Health
Organization)
Provides technical guidance
and sets standards for
pharmaceutical products
globally, contributing to the
improvement of global
health.
NMPA (National
Medical Products
Administration)
Regulates the safety,
efficacy, and quality of
medical products in China,
promoting safe and
effective products for
consumers.

11. Commercialization & SUPAC
Guidelines
1 Market Research
Understanding the market needs,
potential competitors, and target
audience is crucial for successful
commercialization. Identifying unmet
needs and developing a strong value
proposition is key.
2 Intellectual Property
Protection
Securing patents, trademarks, or other
forms of intellectual property
protection is essential to safeguard
the technology and control its
commercialization.
3 Pricing Strategy
Developing a competitive and
sustainable pricing strategy is crucial
for commercial success. Factors like
production costs, market demand, and
competitor pricing should be
considered.
4 Marketing & Distribution
Establishing effective marketing and
distribution channels to reach the
target market is essential for success.
Building strong relationships with key
stakeholders, including distributors
and healthcare professionals, is
important.

12. Practical Aspects and Problems
(Case Studies)
Regulatory Challenges
Navigating different regulatory systems
across countries can be challenging,
requiring thorough documentation and
potential modifications to meet specific
requirements.
Funding and Investment
Securing sufficient funding to support
technology development, research, and
commercialization can be a major hurdle,
especially for early-stage technologies.
Partnering and Collaboration
Finding suitable partners or collaborators to
share expertise, resources, and market
access is crucial for success, but forming
effective partnerships can be complex.
Time and Resources
Technology transfer can be a lengthy
process requiring significant time and
resources, potentially impacting timelines
and overall project feasibility.

13. Technology Transfer
Agencies in India
1 Government agencies and organizations play a crucial role in
facilitating technology transfer, offering guidance, resources,
and support to researchers, businesses, and entrepreneurs.
2 These agencies provide valuable assistance in connecting
inventors and technology developers with potential licensees or
adopters, fostering collaboration and innovation.
3 They offer various programs and services, including intellectual
property management, market research, and financial
assistance to help facilitate successful technology transfer.

14. Asian and Pacific Centre for
Transfer of Technology (APCTD)
Mission
To facilitate technology transfer in
the Asia-Pacific region, promoting
sustainable economic development
and improving the lives of people.
Services
Provides training programs,
technology assessments, and
networking opportunities for
researchers and businesses seeking
to engage in technology transfer.
Focus Areas
Focuses on key areas like
biotechnology, agriculture, and
renewable energy, supporting the
development and transfer of critical
technologies in these fields.
Impact
Has a significant impact on fostering
innovation and sustainable
development by connecting
researchers and businesses with
opportunities for technology
transfer.

15. National Research Development Corporation
(NRDC)
1
Commercialization
2 Technology Evaluation
3 Licensing and Patent Management
4 Market Research
5 Innovation Support
NRDC plays a crucial role in bridging the gap between research and industry, helping to commercialize technologies developed
in Indian research institutions.

16. Technology Information Forecasting and
Assessment Council (TIFAC)
1 Technology Foresight
2 Technology Assessment
3 Technology Transfer
4 Policy Recommendations
TIFAC provides critical insights and recommendations to guide India's technology development and transfer, ensuring
alignment with national priorities and long-term goals.

17. Biotech Consortium India
Limited (BCIL)
150
Startups Supported
100M
Investment
100
Patents Granted
50
Technology Licenses
BCIL is a leading player in promoting biotechnology innovation and
technology transfer in India, playing a pivotal role in fostering growth in
the sector.

18. Technology Bureau for Small Enterprises
(TBSE) / Small Industries Development Bank of
India (SIDBI)
These agencies provide vital support to small and medium-sized enterprises (SMEs) in accessing and adopting new
technologies, enhancing their competitiveness and fostering innovation.The Technology Bureau for Small Enterprises (TBSE) is a
program by the Small Industries Development Bank of India (SIDBI) designed to assist small businesses in adopting advanced
technologies. TBSE provides support for technology transfer, upgradation, and consultancy services to enhance the
competitiveness of small enterprises. It connects businesses with technology providers, facilitates funding, and offers expert
guidance to ensure smooth implementation of technological solutions. By promoting innovation and modernization, TBSE aims
to improve productivity, reduce costs, and help small enterprises compete effectively in domestic and global markets, fostering
growth and sustainability in the small-scale industry sector.

19. Conclusion and Next Steps
WHO's guidelines provide a comprehensive framework for successful
technology transfer, promoting innovation and ensuring equitable access
to healthcare technologies worldwide. Collaboration between
stakeholders, including national governments, research institutions, and
pharmaceutical companies, is crucial for effective implementation of
these guidelines. By working together, we can leverage technology to
improve health outcomes for all.