Breakfast Briefings
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8.00am to 9.15am - Tuesday 30th September to Thursday 2nd October 2008
Due to popular demand, we are delighted to bring to you this Breakfast Briefing series, designed to help you get up to speed on the trends, opportunities and challenges surrounding 3 of the most crucial segments of the pharmaceutical industry.
Through in-depth presentations, roundtable discussion sessions and extensive Q&A, delegates will gather vital industry news and information, get the opportunity to brainstorm their live challenges with their peers from across the global pharmaceutical industry and gain in-depth answers to their most critical challenges.
Each breakfast briefing will involve an in-depth 30 minute presentation by a panel of industry leaders, followed by 30 minutes of roundtable debate, and 15 minutes of Q&A. Come armed with your most business critical challenges and leave with a tool kit of immediately implementable solutions!
Breakfast Briefing 1: 
8.00am to 9.15am Tuesday 30th September 2008
API MANUFACTURING
In Association with: European Fine Chemicals Group
Global Trends Impacting The Manufacturing Of APIs In Europe
- The customers – the patients
- Globalisation and hyper competition
- Manufacturing and distribution standards
- Trade barriers – winners and losers
- Enforcement of existing laws, including counterfeiting
- Prospects for new legislation in the US and Europe
Arnulf Heubner, Senior Director Pharma Raw Materials, Merck KGaA &
Chairman, EFCG Pharmaceuticals Business Committee & EFCG Board Member
Tony Scott, Advisor – EFCG/Cefic Belgium
The issues affecting the global manufacture and supply of APIs affect patient safety, national security, the critical mass of skilled manufacturers, regional employment and wealth generation.
These issues affect everyone in the global supply chain for APIs and any shift toward a level playing field will depend largely upon the actions of governments and their agencies. It is a primary role of trade associations representing API manufacturers such as EFCG (Europe) and SOCMA (USA), to influence governments and other stakeholders to act in the best interests of their members and their local economies and their ultimate customers - the patients.
During this session delegates will gain an overview of the key issues affecting API manufacturing today, and engage in in-depth debate to help drive their strategic objectives and plans for compliant API sourcing.
Breakfast Briefing 2: 
8.00am to 9.15am Wednesday 1st October 2008
BIO PRODUCTION
In Association with: European Biopharmaceutical Enterprises
Bio-Manufacturing Trends in Europe and Emerging Markets
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The technical challenges of biotech manufacturing compared with chemical drug manufacturing
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Optimising partnerships with CMOs for small-scale and large-scale bio production
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Trends in Europe and emerging markets
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Regulatory developments supporting effective bio-manufacturing
Biotechnology is delivering significant advances in human healthcare. Entirely new medicines are being created, notably for rare or previously untreated diseases. Biotech production methods provide safer versions of existing treatments in unlimited quantities and new innovative therapies to satisfy unmet medical needs.
European Biopharmaceutical Enterprises (EBE) is the European trade association that represents 66 biopharmaceutical companies of all sizes operating in Europe. It was established in 2000 as a specialised group of EFPIA and is headquartered in Brussels. Membership in EBE is open to all companies using biotechnology to discover, develop and bring new medicinal products to market.
In this session delegates will get the opportunity to update on the latest global trends in bio production and manufacturing from leading experts in the field, as well as engage in in- depth debate about how they can drive their own bio production forward.
Breakfast Briefing 3:
8.00am to 9.15am Thursday, 2nd October 2008
CLINICAL TRIAL
PARTNERSHIPS
In Association with: Penn Pharmaceutical Services & Client
Working Effectively With CROs To Minimise Research Costs And Maximise Speed To Market Of New Drugs
- Identifying and selecting the most appropriate CRO for tactical and strategic research support
- Establishing value-added ways of working in partnership
- Negotiating win-win contracts and ensuring service levels are consistently met
- Implementing an effective performance measurement and management framework
- Ensuring regulatory compliance, quality and safety
As one of the longest established pharmaceutical services providers, Penn has over 28 years of experience in providing integrated drug development, clinical trial supply and manufacturing services to the international healthcare industry.
From the world's leading innovators to the industry's market leaders, the quality and variety of Penn’s customer base is enviable. Continually challenged by client requirements, changes in regulation and developments within the industry, Penn brings to this seminar a depth of knowledge and wealth of experience that will provide time saving and cost effective solutions.
During this session Penn will be joined by one of their major clients to discuss how they have established a partnership approach to clinical trials that ensures cost-efficiency, trial quality, speed to market and long term strategic result
To register, please email us
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