WORLD BIO SUMMIT 2023

PROGRAM

Program on November 20 

14:00 ~

15:40


Opening Ceremony

Grand Ballroom3F


16:00 ~

18:20

SESSION 1.

Strengthening Capacities for Pandemic Response: Strengthening Vaccine, Pharmaceutical, and Diagnostics Manufacturing and Regulatory Oversight

Park Ballroom

5F


OPENING CEREMONY
20(Mon) November
14:00~15:40
 Grand Ballroom, 3F
14:00~14:40
Opening Ceremony

Opening 

Remarks

KyooHong Cho

Minister, Ministry of Health and 

Welfare, Republic of Korea


Tedros Adhanom Ghebreyesus

Director General, 

World Health Organization(WHO) 

*Video 

Congratulatory

Remarks

Susan Nakhumicha Wafula

Cabinet Secretary for Health, 

Republic of Kenya


Sanjeev Kumar Balyan

Minister of Animal Husbandry and Dairying, Government of India 


Dong-Kun Shin

Chair of Health and Welfare Committee of the National Assembly


Jane Halton

Chair of CEPI Board,Coalition 

for Epidemic Preparedness Innovations(CEPI)


Fatima Yasmin

Vice-President 

for Sectors and Themes, 

Asian Development Bank (ADB)

*Video 


14:40~14:50
Group Photo
14:50~15:40
Keynote Speeches 

Keynote

Speeches

Catharina Boehme 

Assistant Director-General, External Relations and Governance,

World Health Organization(WHO)


Youngmee Jee 

Commissioner, 

Korea Disease Control 

and Prevention Agency(KDCA)


Willo Brock 

Executive Vice President,

External Affairs, FIND


Darrin Morrissey 

CEO, National Institute for Bioprocessing Research and Training

(NIBRT)


Marie-Ange Saraka-Yao 

Chief Resource Mobilisation & 

Growth Officer, 

Gavi The Vaccine Alliance


[ SESSION 1 ] 
Strengthening Capacities for 
Pandemic Response: Strengthening Vaccine, Pharmaceutical, and Diagnostics 
Manufacturing and Regulatory Oversight
 20(Mon) November
16:00~18:20 
 Park Ballroom, 5F

Access to safe and effective drugs, vaccines and therapeutics is crucial for public health, and the COVID-19 pandemic has underscored the importance of reliable and timely access to essential medical products globally. However, ensuring the quality, safety, and efficacy of pharmaceutical products requires effective regulatory oversight. Globally, there is a significant gap in regulatory capabilities across many countries. Only 30% of all National Regulatory Authorities (NRAs) are estimated to have the capacity to carry out essential regulatory functions, according to the World Health Organization (WHO). An effective and fully operational regulatory system is essential to ensure the safety, efficacy, and quality of pharmaceutical products. Regulatory oversight plays a pivotal role in fostering a sustainable and quality-focused local vaccine manufacturing base by establishing a robust regulatory ecosystem. Clear regulatory guidelines and requirements can promote the development of safe and effective vaccines within the country.

16:00~16:05
Opening Ceremony

Sungsup Ra

Deputy Director General and Deputy Group Chief, Sectors Group, Asian Development Bank(ADB)  

16:05~16:15

Setting the scene: 

"Vaccine, Pharmaceutical, 

and Diagnostic Manufacturing

Support Including Regulatory 

System Strengthening 

to LMICs for Pandemic 

Preparedness and Response"

Patrick Osewe

Director-Health, Human and 

Social Development Sector Office, 

Asian Development Bank(ADB)

16:10~16:20

Remarks and Insights

Phayvanh Keopaseuth

Vice Minister, Ministry of Health of Lao PDR 

16:20~16:50
Lessons from countries 
in Vaccine, Pharmaceutical, 
and Diagnostic Manufacturing

[Moderator]

Patrick Osewe

Director-Health, Human and 

Social Development Sector Office, 

Asian Development Bank(ADB)


[Presenters]

Rachel Park

Director, Business Development, Eubiologics, 

Republic of Korea


Sudeep Kumar

Senior Vice President, Biological E, India


Morena Makhoana

CEO, Biovac, South Africa

16:50~17:20
Case Presentations on 
Regulations Capacity Building 

[Moderator]

John Skerritt

Enterprise Professor in Health Research Impact,

University of Melbourne


[Presenters]

Younjoo Park

Director General, National Institute of Food 

and Drug Safety Evaluation(NIFDS), 

the Ministry of Food and Drug Safety(MFDS)


Yvonne Nkrumah

Deputy CEO,

Corporate Services Division of the Food and Drugs Authority(FDA), Ghana


Rogério Gaspar

Director, 

Regulation and Prequalification,

World Health Organization(WHO)

17:20~18:20
Panel Discussion:
Challenges and Way Forward: 
Vaccine, Pharmaceutical, 
and Diagnostic Manufacturing 
Regulatory Support 


[Moderator]

Patrick Osewe

Director-Health of Human

and Social Development Sector Office,

Asian Development Bank(ADB) 


[Panels]

John Lim

Executive Director, 

Centre of Regulatory Excellence
Duke-NUS Medical Centre


John Skerritt

Enterprise Professor in Health Research Impact,

University of Melbourne 


Sudeep Kumar

Senior Vice President, Biological E, India


[Rapporteur]

Jae Kyoun Kim

Health specialist of Human and

Social Development Sector Office, 

Asian Development Bank(ADB) 



Program on November 20


14:00~15:40

Opening CeremonyGrand Ballroom, 3F

16:00~18:20

SESSION 1. Strengthening Capacities for Pandemic Response: Strengthening Vaccine, Pharmaceutical, and Diagnostics Manufacturing and Regulatory Oversight

Park Ballroom, 5F
OPENING CEREMONY
Monday, November 20, 14:00 – 15:40   I   Grand Ballroom, 3F

 

Time
Program
Speaker
14:00~14:40
Opening Ceremony
Opening Remarks

KyooHong Cho

Minister, Ministry of Health and Welfare,

Republic of Korea


Tedros Adhanom Ghebreyesus

Director General, World Health Organization(WHO) *Video

Congratulatory Remarks

Susan Nakhumicha Wafula

Cabinet Secretary for Health, Republic of Kenya


Sanjeev Kumar Balyan

Minister of Animal Husbandry and Dairying, Government of India 


Dong-Kun Shin

Chair of Health and Welfare Committee of the National Assembly


Jane Halton

Chair of CEPI Board,

Coalition for Epidemic Preparedness Innovations(CEPI)


Fatima Yasmin

Vice-President for Sectors and Themes,

Asian Development Bank (ADB) *Video 

14:40~14:50
Group Photo
14:50~15:40
Keynote Speeches

Catharina Boehme
Assistant Director-General, External Relations and Governance, World Health Organization(WHO)


Youngmee Jee

Commissioner, Korea Disease Control and Prevention Agency(KDCA)


Willo Brock

Executive Vice President, External Affairs, FIND


Darrin Morrissey 

CEO, 

National Institute for Bioprocessing Research and Training(NIBRT) 


Marie-Ange Saraka-Yao

Chief Resource Mobilisation & Growth Officer,

Gavi The Vaccine Alliance

* The Time and Content are Subject to Change.

[SESSION 1] Strengthening Capacities for Pandemic Response: 
                          Strengthening Vaccine, Pharmaceutical, and Diagnostics Manufacturing and Regulatory Oversight
Monday, November 20, 16:00 – 18:20   I   Park Ballroom, 5F


Access to safe and effective drugs, vaccines and therapeutics is crucial for public health, and the COVID-19 pandemic has underscored the importance of reliable and timely access to essential medical products globally. However, ensuring the quality, safety, and efficacy of pharmaceutical products requires effective regulatory oversight.


Globally, there is a significant gap in regulatory capabilities across many countries. Only 30% of all National Regulatory Authorities (NRAs) are estimated to have the capacity to carry out essential regulatory functions, according to the World Health Organization (WHO). An effective and fully operational regulatory system is essential to ensure the safety, efficacy, and quality of pharmaceutical products. Regulatory oversight plays a pivotal role in fostering a sustainable and quality-focused local vaccine manufacturing base by establishing a robust regulatory ecosystem. Clear regulatory guidelines and requirements can promote the development of safe and effective vaccines within the country.



Time
Program
Speaker
16:00~16:05
Opening Remarks

Sungsup Ra

Deputy Director General and Deputy Group Chief, Sectors Group, 

Asian Development Bank(ADB)  

16:05~16:15
Setting the scene :
"Vaccine, Pharmaceutical, and Diagnostic Manufacturing Support Including Regulatory System Strengthening 
to LMICs for Pandemic Preparedness and Response"

Patrick Osewe

Director-Health, Human and Social Development Sector Office,

Asian Development Bank(ADB)

16:15~16:20
Insights into Regulatory Strength and Challenges in 
Lao PDR for Pandemic Preparedness

Phayvanh Keopaseuth

Vice Minister, Ministry of Health of Lao PDR

16:20~16:50
Lessons from Countries in Vaccine, 
Pharmaceutical, and Diagnostic Manufacturing

[Moderator]

Patrick Osewe

Director-Health, Human and Social Development Sector Office,

Asian Development Bank(ADB)


[Presenters]

Rachel Park

Director, Business Development, Eubiologics, Republic of Korea


Sudeep Kumar

Senior Vice President, Biological E, India


Morena Makhoana

CEO, Biovac, South Africa


16:50~17:20
Case Presentations on Regulations Capacity Building

[Moderator]

John Skerritt

Enterprise Professor in Health Research Impact, 

University of Melbourne


[Presenters]

Younjoo Park

Director General, National Institute of Food and Drug Safety 

Evaluation(NIFDS), the Ministry of the Food and Drug Safety(MFDS)


Yvonne Nkrumah

Deputy CEO, 

Corporate Services Division of the Food and Drugs Authority(FDA), Ghana


Rogério Gaspar

Director, Regulation and Prequalification, 

World Health Organization(WHO)


17:20~18:20

Panel Discussion:


Challenges and Way Forward: Vaccine,

Pharmaceutical, and Diagnostic Manufacturing

Regulatory Support


[Moderator]

Patrick Osewe

Director-Health of Human and Social Development Sector Office,

Asian Development Bank(ADB) 


[Panels]

John Lim

Executive Director, 

Centre of Regulatory Excellence Duke-NUS Medical Centre


John Skerritt

Enterprise Professor in Health Research Impact, 

University of Melbourne


Sudeep Kumar

Senior Vice President, Biological E, India


[Rapporteur] 

Jae Kyoun Kim

Health Specialist, Human and Social Development Sector Office,

Asian Development Bank(ADB)


* The time and content are subject to change.



WORLD BIO SUMMIT 2023 Secretariat

E-mail: worldbiosummit@korea.kr

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