Conference Team : Combination Products-Safer, more Effective, and more Convenient13-Sep-22
Title

Time

Opening Opening remarks

Lecturer

Moderator

9:00-9:10

Mr. Eiji Watanabe (PDA Japan Chapter)

9:10-10::10

Dr. Hiroko Shibata (National Institute of Health Sciences)

Ms. Morikawa Michiyo (Terumo)

10:10-10:50

J-PDA Medical Device Committee.

Ms. Morikawa Michiyo (Terumo)

Mr. Enrico Barichello (Stevanato Group)

Mr. Tetsuro Odaka(Kyowa Krin)

13:10-13:50

Mr. Yasushi Wakebe(Kistler Japan G.K.)

Mr. Tetsuro Odaka(Kyowa Krin)

Session A Quality assurance for biopharmaceuticals
A-1

Invited educational lecture: Evaluation of protein aggregates/insoluble particulate matters in prefilled syringe products
Session B Risk management of combination products.

B-1

Risk management of combination products.

Exhibition break
B-2

10:50-11:30

Case Study "Design for Impulsive Stress Conditions": how could you decrease the risk of failure in spring-actuated auto-injector?

Lunch & Exhibition
B-3

11:30-12:10
12:10ｰ13:10

Manufacturing process monitoring utilized by crystal piezoelectricsensors.
Session C: Storage and transport at low temperatures.

C-1(Ultra) Low Temperature Performance of COC Polymer Prefillable Syringes

13:50-14:30

Mr. Michael Weber( SCHOTT AG)

Mr. Takuro Kaya(Hirabara engineering Service)

C-2

Thermal packaging solutions for deep frozen shipments

14:30-15:10

Ms. Kristina Kletzel (Va-Q-Tec))

Mr. Takuro Kaya(Hirabara engineering Service)

Exhibition break

15:10-15:50
Session D: Examples of pen/autoinjector development

D-1

Case study: Autoinjector Assembling and Control Processes

15:50-16:30

Ms. Susanne Hall(Vetter Pharma)

Ms. Brigitte Reutter-Haerle(Vetter Pharma)

D-2

Development of customized autoinjector combination products based on platform products ‒ Case study examples

16:30-17:10

Mr.Orfeo Niedermann(Ypsomed AG)

Ms. Brigitte Reutter-Haerle(Vetter Pharma)

17:10-17:50

Mr.Koichi Muramoto(Phillips-Medisize / Molex Japan LLC)

Mr. Shuichi Hatano (Shionogi & Co., Ltd.)

Session E: Conected Device systems and sustainability
E-1

SMART Drug Delivery technologies enables patients safer and more convenient
14-Sep-22
Title

TimeLecturer

Session F: Product development for Asia-Pacific region.
F-1

DMF system in China

Application procedures for pre-ﬁlled syringes

9:00-9:40

Mr. Katsuaki Kojima(WORLDWIDE INTELLECTUAL PROPERTY CONSULTING JAPAN CO., LTD) Mr.Kenta Goto（Takeda Pharmaceutical Company Ltd．）

F-2

Comparative insights into the diabetes self-injection therapy in APAC

9:40-10:20

Mr. Chun Chang(SHL Medical)

Exhibition break

Mr.Kenta Goto（Takeda Pharmaceutical Company Ltd．）

10:20ｰ11:00
Session G: Cybersecurity regulation and Human Factors Engineering for Combination Products

G-1

Regulatory trends for the medical device cybersecurity

11:00-11:40

Mr. Gen Murase(UL Japan)

Mr. Tomohiko Tsurumaru (3M Japan)

G-2

Human Factors Engineering in Combination Product Development. -Practical methodologies common to the global market.

11:40-12:20

Dr. Yanoura Nomane (Becton Dickinson)

Mr. Tomohiko Tsurumaru (3M Japan)

Lunch & Exhibition

12:20ｰ13:20
Session H: Innovation in combination products

H-1

Tentative title: A novel design to make prefilled syringes safer, user friendly and compliant

13:20-14:00

Mr. Rajeev Kabbur (Brevetti Angela)

Ms.Yu Kishi(Janssen Pharmaceutical K.K.)

H-2

Powder dosage in double-chamber syringes

14:00-14:40

Mr. Joan Mele Vidal (Dara Pharmaceutical Equipment)

Ms.Yu Kishi(Janssen Pharmaceutical K.K.)

15:20-16:00

Mr. Felix Mausolf (groninger & Co. GmbH)Mr. Shuichi Hatano (Shionogi & Co., Ltd.)

16:00-16:40

Mr. Akihoro Kumagai(FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd.）Mr. Shuichi Hatano (Shionogi & Co., Ltd.)

Exhibition break

14:40-15:20
Session I: Robot technology in aseptic filling processes.

I-１

How pharma robots can make aseptic fill and finish safer more effective and more convenient
Session J: Syringe and pen development case studies

J-1

Considerations in Combination Product Development Derived from the Experience in Developing our Adalimumab Biosimilar Products
Session K：Panel discussion

KClosing

Panel discussion (answers to pre-questions and discussions)

16:40-17:30
17:30