PROGRAM | Program

回顾鼻喷剂和吸入剂药物研发所面临的挑战;

Inhalation Asia 2017 (IA17) will start at lunch time on Wednesday 13 September 2017 and will finish on Friday 15 September 2017 at 5 O’Clock in the afternoon. IA17 will take place at the University of Macau, Macau (China).  IA17 will be a multi strands event with lectures, posters, technology products and services exhibition, teaching and networking sessions.

The full programe of IA17 can be found here as a dowloadabble PDF file: IA17 PROGRAME BOOK

The event consists of 4 parts:

* The exhibition of products, services and equipment. The full list of exhibitors can be found here: EXHIBITORS

* The training Workshops (see below): WORKSHOP PROGRAME.

* The event timetable can be found here: LECTURES TIMETABLE. The abstracts of the lectures are on this page: LECTURES ABSTRACTS.

* The poster presentations, the abstracts of the posters can be found here: POSTER ABSTRACTS.

WORKSHOPS: IA17 is pleased to offer training on inhalation technology via 8 workshops. Attendance of the the workshops is free for IA17 Bona Fide attendees. If you wish to attend, you must register with the presenters so they can send you all the relevant information and training materials:

Workshop 1: Advanced analytical techniques for the testing of orally inhaled and nasal drug products: How to build confidence in the in-vitro data for your generic product (Taught by Intertek)REGISTER HERE FOR WORKSHOP 1
The use and significance of real breathing profiles for emitted dose and impactor testing of OINDPs; The use of Morphologically Directed Raman Spectroscopy (MDRS) to determine in-situ PSD for powder and suspension formulations; Advanced lung dissolution models; How to use the above tools in conjunction with conventional IV-BE tests to avoid costly failures in the clinic; What else can we add to move towards true 'IV-IVC'?
 
Workshop 2: Dry Powder Inhalers: The critical role of Primary Packaging (Taught by AMCOR). REGISTER HERE FOR WORKSHOP 2
The primary packaging material fulfils different tasks regarding drug protection and device functionality. Regulatory submission documentation has to demonstrate that the material will repeat these tasks in every device throughout the shelf life of the device; The submission dossier has to demonstrate that there is no risk to the patient by e.g. an insufficiently controlled upstream supply chain, non-adequate production processes or environmental conditions in which the material is produced; To avoid delays or failing of the approval process, it is crucial that different guidelines such as USO661 are taken into consideration in all phases of the development process; The selected supplier must be able to support the material qualification through robust data about material properties and production processes to ensure a complete submission dossier, enabling a fast and smooth filing process.
在此討論會中,將以泡罩包裝乾粉吸入制劑做為例子,說明不同開發階段所面臨的不同流程,以及如何與初級包裝材料供應商相互合作,以達到最順暢的申報過程; 初級包裝須滿足有關藥品保護以及裝置性能的多項需求; 提報的審查文件則是須證明此包材在有效期內,在每裝置中皆能有相同的性能; 提報的審查文件須證明此包材在不同層面上,不會對病人造成任何風險,例如:上游供應商的管控、製造流程或是生產環境等因素; 為了避免申報過程有任何延誤或是失敗,在開發階段已須將不同規範考量進去,例如:USO661等; 所選定的包材供應商需具備能提供產品驗證的完整相關資訊的能力,例如:產品特性及製造流程等,以確保有個迅速且流暢的申報過程。
 
Worhsop 3: Considerations for non-clinical inhalation drug development (Taught by ENVIGO). REGISTER HERE FOR WORKSHOP 3

Inhalation delivery trends in US and Europe
Drug formulation considerations;Rodent and non-rodent inhalation dosing;Aerosol generation and monitoring;Case Studies

关于吸入药物研发非临床阶段的一些思考
欧美的吸入给药发展趋势;药物制剂的考虑;啮齿类和非啮齿类动物的吸入剂量;气溶胶的产生与监控;案例分析

Worhsop 4: Accelerate Respiratory Drug Product Development with Spray Pattern Analysis as a Sensitive Screening Tool (Taught by PROVERIS). REGISTER HERE FOR WORKSHOP 4
Review challenges with Nasal and Inhaled product development; Describe the need for rapid and sensitive methods for evaluating device component design; Use of spray pattern and Quality by Design principles to understand the interaction between formulation, device, and patient usage; 
Case study: understanding the effects of device component interactions on spray performance
对于评估释药装置各部件设计的灵敏测试方法的需求; 利用喷雾模式和质量源于设计的理念来理解药物配方,释药装置,以及患者使用的相互关系; 案例研究:了解释药装置各部件对喷雾性能的影响
 
Workshop 5: In vitro Bioequivalence Testing for Inhaled and Nasal Spray Products (Taught by PROVERIS). REGISTER HERE FOR WORKSHOP 5
Review of the current FDA required in vitro tests; Similarities and differences between inhaled and nasal product guidances; Comparisons between FDA and other regulatory agencies; Common issues observed in BE testing for Spray Pattern and Plume Geometry; 
回顾FDA的体外测试要求; 法规对于鼻喷剂和吸入剂药物测试要求的相似点和不同点; FDA和其他药品监管机构的法规比较; 喷雾模式和喷雾形态分析的常见问题.
 
Workshop 6: Physiochemical analysis techniques for nasal spray IVBE assessments (Taught by MALVERN). REGISTER HERE FOR WORKSHOP 6
What are the physicochemical (Q3) equivalence testing requirements for nasal sprays?; What role do material characterisation methods have within the FDA's IVBE guidance?; How can extending Q3 equivalence testing to consider other formulation aspects can aid deformulation?
 
Workshop 7: Avoiding some of the newer problems in MDI manufacture (Taught by MEXICHEM Fluor). REGISTER HERE FOR WORKSHOP 7

Mexichem provides the majority of the world's medical HFA propellants, and often gets involved in sorting problems out in the MDI.This update will cover topics such as improving can fill weight control; avoidance of explosion risk in manufacture and minimising stability problems with unstable drugs, as well as some more traditional ones.

Workshop 8: Inhalation Lactose, Influence on flow and deposition (Taught by DFE Pharma). REGISTER HERE FOR WORKSHOP 8
Inhalation market; Lactose in dry powder inhalers; Powder flow and dry powder inhalation; Lactose and drug deposition; How DFE can support your formulation DFE.
吸入用药市场回顾; 乳糖在干粉吸入制剂的应用​; 粉末流动对DPI的作用​; 乳糖对于药物肺部沉积的影响; 如何支持你们的处方设计
 
Workshop 9: How AR/VR will impact inhaled drug delivery (Taught by Worrell Inc). REGISTER HERE FOR WORKSHOP 9
Diseases like COPD and asthma are affecting an increasing amount of the population and, due to compromised air quality, smoking, and genetics. Additionally, this increasing population of users are presented with confusing and difficult-to-use DPIs due to the increased task burden when compared to PMDIs. Simultaneously, mobile computing technology is making its way to our eyes while scanning our environment, blurring the digital and physical realms. Recent announcements from Apple (ARKit), Magic Leap, Facebook and Microsoft hint that they are working on mass-market consumer glasses that can overlay information.
 
 

Inhalation Asia is committed to open access to its conference archive. Access to this information is free of charge, but does require you to register on our database and to agree to respect the copyrights of the authors. Please make reference to Inhalation Asia every time you make use of the material you download.

You can access the abstracts and presentations of previous Inhalation Asia events on this page: www.inhalationasia.org.