International Summit for Pharmaceutical Packaging&Drug

Delivery System

Shanghai New International Expo Center SNIEC W3M10

24-25 JUNE 2015

International Summit for Pharmaceutical Packaging&Drug

Delivery System

主办单位 同期联袂

Focus on Regulation of Pharmaceutical

Packing Materials and Excipients

The pharmaceutical industry is undoubtedly one of the most potential industry, known as the "eternal sunrise industry", which also makes the pharmaceutical packaging industry has obtained the huge development space. According to the Research Report on global pharmaceutical packaging insti-tutions forecast from authoritative organization, year compound growth rate of the global pharmaceuti-cal packaging demand is 5.51% in 2010-2015; the market demand will reach about US 62 billion until 2015. Developed countries such as USA, Western Europe and Japan accounted for a slight decline in demand, Chinese pharmaceutical packaging demand will account for around 8.64%, amount to around US 5.3 billion. The Chinese government launched a series of projects to enhance the quality of drugs and pharmaceutical packaging has a strong growth. Facing such a broad prospect, pharmaceutical packaging industry needs to seize this opportunity, constantly develop new varieties, inject fresh impe-tus for industry and accelerate industrial upgrading and transformation. 2015 Pharmaceutical Packaging Innovation and Management Conference will be closely linked to the domestic and foreign industry hot topic to explore new materials and pharmaceutical packaging technology, offering exchange platform with global pharmaceutical, packaging industry experts, appre-ciating forefront industry information, substantiating your pharmaceutical packaging innovation trip as well as securing your leading position in the industry!

Pharmaceutical Packaging Suppliers

12.70%

20.63%

25.40%

41.27%

ENTERPRISES

ENTERPRISES

021-3339 2312Contact：Mr.Li（Ben）

WHO ATTEND?WHO ATTEND?

Local Pharmaceutical Enterprises

Foreign Pharmaceutical Enterprises

Testing Companies

ManagersSupervisorsManagersSupervisors

Engineers，AnalystsEngineers，Analysts

DirectorsGeneral ManagersDirectorsGeneral Managers

OthersOthers

Dr. James R. Scull/ Global Director of Heath Science/ NSF

Testing for extractables and leachables is an area which is receiv-ing much focus from the FDA.This presentation will discuss the methods, techniques and instrumentation employed throughout an extractable and leachable study. From the beginning stages of the controlled extractions through the identifications, method development and validation to the final migration study will be analysed.Through out these stages the strengths and weaknesses of the various techniques and methods as well as some obstacles that were encountered along the way will be focused on.

14:00

Huimin Sun / Deputy Director of Medicinal Auxiliary Materials and Packing Material /NIFDC

Huimin Sun / Deputy Director of Medicinal Auxiliary Materials and Packing Material / NIFDC

Rong Cai/ Deputy director/ SHPMCC

Hui Yu/ Director/ ZIFDC

10:05

It is planned that in 2015 the separate registration and approval of pharmaceutical packing materials or supplementary materials will not be carried out, but it will be registered and examined together with the targeted medicines or drugs. For those pharma-ceutical manufacturing enterprises, the change in this policy means more responsibility upon products quality needs to be taken. In this speech, the speaker will expose the latest results of this policy.

09:30

10:00

12:00

12:20

11:40

Safety and Compatibility in Drug and Drug Packaging

CFDA New Guidance on Regulation of Pharmaceutical Packaging Materials

Registration

Welcome Opening Address by Chairman

Two-Piece Hard Capsules,Equipments and Technology

Lunch break

Experts Q & A

Tea Break11:20

The study of leachables and extractables is the hardest and hottest issue in recent years. A system needs to be built to assess them in packaging and control the amount to make sure the safety of drugs. There are two ways to identify: Active identification and Passive identification. The passive one is to explore the design space of packaging, if the manufacturing procedure of packaging and drugs could be built, for example the design space of leachables could be specified, then from the part of leachables, the drugs that meet the requirements could be compatible with the packaging, there is no need to test by liquor. The passive one, on the other hand, is to test leachables till before expiration date.

Application of Quality by Design (QbD) Principles to Extractables and leachables Assessment

Tea Break

Packaging Materials Selection and Quality Control

Vera Liu/ R&D Manager/ Baxter

Conference Closes

Vera Liu/ R&D Manager/ Baxter

Jiacheng Liu/ Product Manager/ Ompi

Honghao Wang/ General Manger/ Shandong Lu Xin Tianyi

16:10

Copyright © International Summit for Pharmaceutical Packaging & Drug Delivery System All Rights Reservedved

11:00 the Impact of Filing System on the Industry

Peng Han/ Deputy Director/ National Pharmacopoeia Committee

HPMC capsule, hard gelatin capsule and PEG-gelatin capsule and their characteristicsLineup of Machines for filling, band-sealing, inspection and imprinting machines for capsules and tablets

Tohru Kokubo/ R&D Manager/ Qualicapa

Day 1 – 24th June

14:30

15:00

15:20

16:00

Yangbao Le/ Equipment specialist/Bristol-Myers Squibb Company

Richard Turner/Global Business Development Director- Pharmaceutical/Presspart

The canister, from safe containment to integral part of an efficient drug delivery system.The canister, valve and actuator relationship, meeting the demands of new and complex formulationsPatient safety, personal health management and compliance, why? And how?

13:30

Dimitri Grasswill/Global Innovation & Development Director/Nemera

Dr. Vassilios Kanellopoulos/Business Development Director/PDD Innovation (UK)

10:30

10:00

11:35

11:15

Respiratory Drug Delivery: Market Trends & New Developments

Child-Resistant Packaging: Update on International Legal Requirement and How to Implement Child-resistant Packaging Technologies

Promote Pharmaceutical Child-resistant Packaging, Protect Children to Grow in Good Health

Latest Glass Technologies for Pharmaceutical Packaging

Designing Breakthrough Drug-Delivery Devices – A Holistic Review of Best Practice Techniques that Lead to Commercial Success

Tea Break11:00

Packaging Global Sourcing Strategy from an International Pharma Company Perspective

Frederic Jailloux/Managing Director/VAL-U Advisory (formly Procurement Director at GSK)

Dr. Folker Steden/Director Product Management & Scienti�c Services/SCHOTT AG Mitterteich

Day 2 – 25th June

14:00

Weimin Zhang/Deputy-General Secretary/ China National Pharmaceutical Packaging Association (CNPPA)

Child-resistant packaging and devices: a panorama of regulatory guidances. Regional approaches in the USA, Europe and ROW.Key considerations to get a child-resistant senior-friendly package: Cognitive and ergonomic considerations.

Examples of implementation of child-resistant solutions on dispensing devices: specifications, design and user tests.

Introduce Successful leading of international development projects in pharmaceutical industry.How to identify customer needs and provide solution to achieve customer satisfaction.

Panel Discussion: Outlook for Injectable Device for Biopharma and Biosimilars in China: Challenges & Opportunities

14:30

West pharma

Schott

Johnson & Johnson

Conference Closes15:30

12:00 Lunch Break

Different technological solutions available for pharmaceutical applications

Contact Person：Mr.Ben Li Mob: +86 15921440584Email:BenLF.Li@ubmsinoexpo.com

Human-Centred Design in innovationThe importance of stakeholder-mappingDeep user insight using ethnographyMatching technology to customer needsThe digital ecosystem for drug delivery devices

Business Development, Branding and Imaging and Scientific service for all glass tubing applications (pharmaceutical and special glasses). Reducing the quality complaints significant through technical trainings and glass workshops.

"Innovations in respiratory device development - now, tomorrow and on the horizon"