10-Sep-24
Title
OpeningTime
9:30-9:40

Opening remarks

Lecturer

Moderator

Mr. Eiji Watanabe(PDA Japan Chapter)

Session A Product Development (Formulation Design)
A-1

Comprehensive countermeasures to reduce proteinaceous visible particles (VP) in liquid monoclonal antibody

products
Exhibition break
A-2

B-1

9:40-10:20 Mr. Hitoshi Sasaki（CHUGAI PHARMACEUTICAL）
10:20-10:50

Autoinjectors, Obesity, and Cardiometabolic Diseases: Development of Human Soft Tissue Simulation and10:50-11:30 Dr. Eric Linvill (SHL Medical)
Physical Test Models to Study Autoinjector Activation PerformanceSession B: Educational Lectures: Case studies of new medical device development
Development of novel cardiovascular surgical patch

Mr. Hiroaki Suzuki(Vetter Pharma)- New options for surgical operation for congenital heartdiseases Lunch & Exhibition

11:30-12:10 Mr. Kentaro Fujinaga(Teijin)

Mr. Hiroaki Suzuki(Vetter Pharma)

Ms. Michiyo Morikawa(CM Plus)

12:10ｰ13:10
Session C: Human Factors Engineering

C-1

Human engineering in autoinjectors

13:10-13:50 Mr. Nemoto Hajime(zenius)

C-2

Connecting Usability and Meaningfulness: Enhancing Device Development to Best Serve the End User

13:50-14:30 Ms. Amanda Tilles, Mr. Paul Erik Fabricius (Phillips Medisize) Mr.Tomohiko Tsurumaru（Solventum)

Exhibition break

Dr. Takeshi AKIYAMA( SIGMAXYZ)

Mr.Tomohiko Tsurumaru（Solventum)

14:30-15:00
Session D: Components of Combination Products

D-1

Defining Attributes for Optimum Performance of Prefilled Syringe Systems

15:00-15:40 Ms. Ashwini Bhisikar（Datwyler）

Mr.Paolo Golfett (Stevanato Group)

D-2

Development of a pre-fillable syringe for biologics application with focus on the auto-injector use

15:40-16:20 Dr. Cristina Schitco(SCHOTT Pharma)

Mr.Paolo Golfett (Stevanato Group)

D-3

How a CDMO can support Pharma Partners in Primary Packaging components selection:

16:20-17:00 Ms. Vincenza Piront（Recipharm）

Mr.Paolo Golfett (Stevanato Group)

Mixer

17:10-19:10

11-Sep-24
Title

Time

Lecturer

Moderator

Session E: Regulatory Trends for Combination Products
E-1

TR 73-2 Application of EU Medical Device Regulation to Prefilled Syringes.

9:00-9:40

E-2

Digital Health for injectable treatments – success stories – and regulatory environment

9:40-10:20 Mr. Orfeo Niedermann(Ypsomed)

Exhibition break
E-3

Mr. Daniel Martinez (Stevanato Group)

Mr.Kenta Goto（Takeda Pharmaceutical Company Ltd.）Mr.Kenta Goto（Takeda Pharmaceutical Company Ltd.）

10:20-10:50

Global regulatory policy landscape for combination products impacting pre-filled syringes and advanced injection devices( (Pre-recorded Lecture)

10:50-11:30 Mr. Sujith Kallur(Becton Dickinson and Company)

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

11:30-12:10 Mr. Takuya Matsui(Cambridge Consultants)

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

Session F: Sustainability
F-1

Improving Integration of Sustainable design principles into combination product development

Lunch & Exhibition

12:10ｰ13:10
Session G: Manufacturing environment management, in-process inspection

G-1

Contamination Control Strategy – A holistic approach to achieve microbial “no growth”

13:10-13:50 Dr. Helen Sauter(Vetter Pharma)

Ms. Brigitte Reutter-Haerle(Vetter Pharma)

G-２

Practical Approaches within Automated Visual Inspection to manage Difficult-to-Inspect Parenterals (DIP) and meet
Container Closed Integrity (CCI) Requirements

13:50-14:30 Dr. Takaya Uno(Syntegon Technlogy)

Mr.Shiuhei Mieda (Daiichi Sankyo Co.Ltd.)

G-3

Approach to developing an efficient redundant filtration process

14:30-15:10 Mr. Taichi

Hanada (Merck)

Mr.Shiuhei Mieda (Daiichi Sankyo Co.Ltd.)

15:40-16:20 Dr. Hideyasu Fujiwara ( Nippon Becton Dickinson)

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

Exhibition break

15:10-15:40
Session H: Patient Medication Adherence

H-1

Trends in Improving Patient drug adherence.

Session I: Clinical Development of Combination Products (Pre-recorded Lecture)
I－1

PFS, decentralized clinical trials, and the future of drug development

16:20-17:00 Mr. Timothy Pang（Citeline/Evaluate Pharma)

J-1

Q&A and panel discussion

17:00-18:00 Mr. Eiji Watanabe(PDA Japan Chapter)

Closing remarks

18:00-18:10 Mr. Eiji Watanabe(PDA Japan Chapter)

Session J: Q&A and panel discussion
Closing

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