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Good Development Practice Conference:
Book part 1 and part 2 of the conference simultaneously and save up to EUR 400,-
18-20 May 2010
Vienna, Austria
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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18-19 May 2010 Part I Quality by Design & Efficiency in Pharmaceutical
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Objectives
During this part of the conference, representatives from authorities as well as specialists from the pharmaceutical industry share their expert knowledge on how Quality by Design can be implemented in Pharmaceutical Development. Hear about best practices from early development up to process transfer and learn how Quality by Design (QbD)and can be realised.
Background
In the development of new pharmaceutical products, it is a need to design and establish sound and appropriate products and processes. New aspects like ICH Q8, PAT and Quality by Design need to be considered and the developed medical product has to be to be producible and get a fast approval.
Overall, Quality by Design has to be seen as an overarching paradigm and an interdisciplinary system from development to production. It is a systematic approach emphasising enhanced product and process understanding. Ideally, QbD already starts in the early design phase of a drug product where both patient needs and process design should be kept in mind. During the following and ongoing design of process and product, it is important to constantly determine critical quality attributes and to understand how process parameters affect these attributes.
Besides this, knowledge and process transfer have to be well organised and managed, in parallel with a sound development work.
19-20 May 2010 Part II Formulation Development & Manufacturing of Paediatric Drugs
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Objectives
Since December 2006, the Regulation (EC) No 1901/2006 on Medicinal Products for Paediatric Use (the 'Paediatric Regulation') is effective and mandatory for all pharmaceutical companies developing new products.
At this part of the Conference, all relevant aspects of paediatric formulation development and manufacturing will be addressed. Questions like suitable dosage forms, acceptable daily intake, taste masking, dosing accuracy, manufacturability and compliance issues will be discussed in various case studies.
The development of paediatric formulations requires specific knowledge and skills combined with dedicated pre-clinical work and the flexibility to introduce new and sophisticated dosage forms to both development and production.
Background
The Regulation has been dramatically changing the development of medicinal products in Europe. So far only few medicinal products have had a specific approval for paediatric use. Off-label-use was and still is widely spread. The aim of the regulation is to improve the provision of secure suitable medicinal products for children from the age of 0 to 17. On the other hand, the implementation of the requirements will drive complexity and investments for the pharmaceutical industry; new development strategies, new formulations and more resources are needed. The overall approach and understanding of pharmaceutical development will change.The pharmaceutical industry needs to integrate all the paediatric aspects in the complete development process and has to assess the paediatric use for both products in early and late development and already authorised products.
Data needs to be generated for Marketing Authorisation of all new products since July 26, 2008 and new indications, pharmaceutical dosage forms and routes of admission since January 26, 2009. In many cases, pharmaceutical industry needs to develop new paediatric formulations. Hence, a sound paediatric development strategy is needed, addressing and considering various challenges.
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