CPhI Japan 2022 provides online content for those who cannot attend on-site event.

Please watch the session to talk about the latest regulatory trends in Japan and overseas and the attractiveness of Japanese APIs.

Thank you for joining CPhI Japan Webinars

【1】“How Japanese API manufacturers can make you more competitive”

【Part-1】 Special speech

The excellence of drug substances made in Japan

Mr. Yoshihiro Tomita

President, Tomita Pharmaceutical Co.,Ltd.

【Part-2】 Presentation

Breakthrough Peptide Manufacturing 

by Molecular Hiving(TM)

SPERA NEXUS, Inc./ Jitsubo CO., LTD.

 

Challenges and Opportunities for small molecule CDMO

Juzen Chemical Corporation

 

Development of Ru-Catalysts (DENEB®, RUCY®, Ru-MACHO®)

and Its Application

Takasago International Corporation

[Supported by Japan Bulk Pharmaceutical Manufacturers Association]

   [ For American Time Zone ]   

17th May 2022

AM 05:00- AM 07:00

   [ For European Time Zone ]   

18th May 2022

PM 09:00- PM 11:00

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【2】Are You Ready For CTIS? What You Need To Do And When You Need To Do It

 

The new EU Clinical Trial Regulation is finally here, are you ready?

Watch this webinar again for an overview of

the EU Clinical Trial Regulation (EU CTR)

and Clinical Trial Information System (CTIS) and how you can prepare for

the broader scope of content that will be made public.

We will help you understand the major differences between

the current EU Directive and new regulation,

what content will be made public,

new timelines for keeping content up to date,

and what you should be doing to get ready internally.

Thomas Wicks  

Chief Strategy Officer, Informa Pharma Intelligence

Francine Lane  

Senior Director, Product Management, Informa Pharma Intelligence

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   [ For American Time Zone ]   

19th May 2022

AM 05:00- AM 06:00

   [ For European Time Zone ]   

20th May 2022

PM 09:00- PM 10:00

【3】Revision of the Pharmaceuticals and Medical Devices Act and the GMP Ministerial Ordinance and the activities of the Kyoto Prefectural Pharmaceutical Affairs Support Center

In this presenation we will explain the development of the legal

compliance system that came into effect in August 2021,

which is part of the amended contents of the Act on Securing Quality,

Efficacy and Safety of Products Including Pharmaceuticals and Medical

Devices (the so-called Pharmaceuticals and Medical Devices Act),

which was revised at the end of 2019. We will also reference

the GMP Ministerial Ordinance that was revised in April 2021 and

came into effect in August in the same year. In addition,

we will introduce the activities of the Kyoto Prefectural Pharmaceutical

Affairs Support Center in connection with

these revisions of laws and regulations.

 

Mr. Ryoichi Tanaka

Section Head                                                              

Department of Health and Welfare                                                                     

Pharmaceutical Affairs Division                                                          

Kyoto Prefectural Pharmaceutical Affairs Support Center

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   [ For American Time Zone ]   

24th May 2022

AM 05:00- AM 07:00

   [ For European Time Zone ]   

25th May 2022

PM 09:00- PM 11:00