Trends in Generic Drug Development
• Strategies and opportunities for smaller and niche generic companies
• New technologies in the generic drug development
• Is it a threat that big pharmaceutical companies incorporate more generic drug activity?
• Define core competences and outsource other activities
• What percentage or part of the process should be outsourced, when and to whom?
• Generic pharmaceutical life cycle management - Extending lifecycles and portfolio growth
Theodore Iliopoulos, Vice President of the Management Board,Polpharma
IMI — The Innovative Medicines Initiative and the Hungarian National Platform for Drug Innovation
• EU Innovative Medicines Initiative (IMI)
• Drug innovation
• Hungarian platforms
Prof. Ádám Vas, Senior Research Adviser, Gedeon Richter
Timing of Third Country GMP Inspections Including API Manufacturers
• Inspect foreign API manufacturers or rely on the Qualified Persons approval?
• How to schedule GMP inspections in third countries?
• How to prepare for these GMP inspections?
Prof. Tamás Paál, President of the Operative Board, OGYI — The National Institute of Pharmacy in Hungary
Effective Production Optimization — Generate More Products with the Same Resources
• How to monitor and optimize production process maximizing OEE?
• How to eliminate the issues with none qualitative material?
• How to optimize stock keeping of spare parts and consumables?
Péter Bona, Sales and Marketing Manager, Com-Forth - GE Intelligent Platforms
Biotechnology of 21st Century in Medicine - The Future of the Red Biotechnology
• The future of tailored medicine
• Progress of molecular biology and genetic engineering
• Challenges of enabling technologies in emerging and global markets
• Controversies: North — South conflict, differences between original medicines
and generics, value of patents versus “family” secrets
Prof. Tomasz Twardowski, President, PFB — The Polish Biotechnology Federation
Cost Optimization Potentials & Innovations in Production - Implementation of Disposables in the Process Development and Commercial Production
• Operational areas and basic requirements
• Timelines of implementation
• Benefits and scale up challenges
Prof. Wilfried Wöhrer, Director Pilot Plant Operations, Baxter Innovations
How can Engineering Support GMP?
• Overview of regulations and standards regarding engineering
• Design, installation, qualification and operation with focus on the weakest link - Human errors
• Documentation - An old enemy?
• Management of contractors
• Improvement possibilities — Towards maintenance excellence
• GMP knowledge of engineers — Education
István Király, Director Quality Assurance, GSK
Reduced Life Cycle Costs in Biotech/Pharma Production — Ways to more Productivity
• Cost drives in Biotech/Pharma production
• Potentials for cost reduction and more efficiency in production
• Value add of standardized technology along the value chain of Biotech/Pharma production
Dr. Eckhard Roos, Head of Global Industry Segment Management Process Automation, Festo
Saving Costs and Being Environmental Friendly by Introducing Green Chemistry Related Programs
• Generating meaningful green chemistry metrics & targets for APIs that engage scientists within project teams
• Designing a green manufacturing process - A case history from a process chemistry perspective
• Cost savings delivered by implementing a move towards more attractive green solvents across a global network of sites
• Practical tools & guidance for scientists that facilitate changes in working practices that deliver financial benefits
Dr. Laurence Harris, Head of Analytical Development Department and Associate Research Fellow, Pfizer
Outsourcing Regional Logistics in the Pharmaceutical Industry – The Key Success Factors
• The right designation and set up of the region
• Avoid catches during the tender process
• Thorough implementation
Menyhárt Zoltán, Business Development Director, CEMELOG
Strategy by a European Company to Strengthen its Position in the Eastern European Market
• Company overview - XELLIA PHARMACEUTICALS Group, Copenhagen
• Product presentation - APIs and Finished Dosages
• Global marketing strategies based on a business-to-business concept
• The local marketing approach for Eastern Europe
• Technical projects made in collaboration with customers, GTS, Xellia as CMO
• Site Budapest – Example of a typical Xellia site with running base production and projects
Alfredo Cavalli, Director Strategic Commercial Development and Sales, Xellia Pharmaceuticals ApS
Tom Andresen, General Manager Budapest, Xellia Pharmaceuticals ApS
Small and Smart - 2D Data Matrix in the Health Care Sector
• Laws and regulations worldwide for Pharmaceutical and Medical product identification
• Regulation changes for Track & Trace
• The ideal solution: 2D Data Matrix
• Implementation of 2D identification system - Lessons learned
Zsolt Hergyó, Supply Chain Manager CEE, BBraun Medical Ltd.
Pharmaceutical Expenditure in Hungary in an International Context
• Scarcity of public resources draws attention to the cost-containment measures of pharmaceutical expenditure
• Current pharmaceutical expenditure of Hungary is assessed related to the economic status of the country, benchmarks from other OECD countries with special focus on V4 countries
• International trends of the global pharmaceutical market are also valid in Hungary
Dr. Zoltán Kaló, Director, Health Economics Research Centre, Faculty of Social Sciences at Eötvös Loránd University and CEO, Syreon Research Institute