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Day 5 - CET/CEST (Cent Europe Summer, GMT+2)
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Day 5 - CET/CEST (Cent Europe Summer, GMT+2)
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08:00 - 09:0060 mins
Regulatory Affairs in Global Markets: APAC Region
Conference Registration
08:00 - 09:0060 mins
Regulatory Affairs in Global Markets: LATAM Region
Conference Registration
09:00 - 09:1010 mins
Regulatory Affairs in Global Markets: APAC Region
Chairperson’s Opening Remarks
- Ed Woo - Regulator Affairs Lead, APAC, Philips
- Kazuhisa Senshu - Chief Clinical & Regulatory Affairs Officer, Terumo Japan
09:00 - 09:055 mins
Regulatory Affairs in Global Markets: LATAM Region
Chairperson’s Opening Remarks
- Iván Calderón - Executive Director of Marketing Authorisations and Establishments, COFEPRIS
- Maria de la Luz Lara Méndez - CEO, Udelá
09:05 - 09:3025 mins
Regulatory Affairs in Global Markets: LATAM Region
Introduction to Medical Devices in Latin America
- Iván Calderón - Executive Director of Marketing Authorisations and Establishments, COFEPRIS
- Maria de la Luz Lara Méndez - CEO, Udelá
09:10 - 10:2575 mins
Regulatory Affairs in Global Markets: APAC Region
Introduction of MD in Australia, Japan, S. Korea
- Ed Woo - Regulator Affairs Lead, APAC, Philips
- Kazuhisa Senshu - Chief Clinical & Regulatory Affairs Officer, Terumo Japan
09:30 - 10:2555 mins
Regulatory Affairs in Global Markets: LATAM Region
Overview of regulatory procedures in Brazil, Mexico, Argentina and Colombia
- Iván Calderón - Executive Director of Marketing Authorisations and Establishments, COFEPRIS
- Maria de la Luz Lara Méndez - CEO, Udelá
10:25 - 10:5530 mins
Regulatory Affairs in Global Markets: APAC Region
Networking Break
10:25 - 10:5530 mins
Regulatory Affairs in Global Markets: LATAM Region
Networking Break
10:55 - 12:2590 mins
Regulatory Affairs in Global Markets: LATAM Region
Overcoming regulatory challenges in Brazil, Mexico, Argentina and Colombia and specific device issues
- Iván Calderón - Executive Director of Marketing Authorisations and Establishments, COFEPRIS
- Maria de la Luz Lara Méndez - CEO, Udelá
11:00 - 12:2585 mins
Regulatory Affairs in Global Markets: APAC Region
Overview of regulatory environment
- Ed Woo - Regulator Affairs Lead, APAC, Philips
- Kazuhisa Senshu - Chief Clinical & Regulatory Affairs Officer, Terumo Japan
12:25 - 13:2560 mins
Regulatory Affairs in Global Markets: APAC Region
Networking Lunch
12:25 - 13:2560 mins
Regulatory Affairs in Global Markets: LATAM Region
Networking Lunch
13:25 - 13:305 mins
Regulatory Affairs in Global Markets: APAC Region
Chairperson’s Opening Remarks
- Ed Woo - Regulator Affairs Lead, APAC, Philips
- Kazuhisa Senshu - Chief Clinical & Regulatory Affairs Officer, Terumo Japan
13:25 - 13:305 mins
Regulatory Affairs in Global Markets: LATAM Region
Chairperson’s Opening Remarks
- Maria de la Luz Lara Méndez - CEO, Udelá
- Iván Calderón - Executive Director of Marketing Authorisations and Establishments, COFEPRIS
13:30 - 15:15105 mins
Regulatory Affairs in Global Markets: APAC Region
Introduction of MD in ASEAN region
- Ed Woo - Regulator Affairs Lead, APAC, Philips
- Kazuhisa Senshu - Chief Clinical & Regulatory Affairs Officer, Terumo Japan
13:30 - 15:15105 mins
Regulatory Affairs in Global Markets: LATAM Region
Working with local consultants, host companies and distributors
- Iván Calderón - Executive Director of Marketing Authorisations and Establishments, COFEPRIS
- Maria de la Luz Lara Méndez - CEO, Udelá
15:45 - 17:1590 mins
Regulatory Affairs in Global Markets: APAC Region
Overview of regulatory environment
- Ed Woo - Regulator Affairs Lead, APAC, Philips
- Kazuhisa Senshu - Chief Clinical & Regulatory Affairs Officer, Terumo Japan
15:45 - 17:1590 mins
Regulatory Affairs in Global Markets: LATAM Region
Important requirements in Latin America
- Iván Calderón - Executive Director of Marketing Authorisations and Establishments, COFEPRIS
- Maria de la Luz Lara Méndez - CEO, Udelá
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