 Clinical Trials Summer School
This three day course is an introduction for people entering into Clinical Trials. Senior representatives of the pharmaceutical industry and associated bodies will provide discussion and clarification of the key areas of importance to someone entering the industry.
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 Particle Design for APIs and Drug Products
This 2nd time event is designed to bring together industry professionals together from formulation, preformulation and chemistry to share experiences and learn about the latest techniques and ideas used in design particles. Particle design is becoming more widely used by industry to maximise the functionality and properties of the particle, ensure it has the desired effect. This conference covers characterisation, production and formulation of designed particles, as well as a 1 day symposium on nanoparticles, looking into the various challenges faced by industry in this area.
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 Pharmaceutical Summer School
This 3-day residential course will take you step by step through the entire drug development pipeline, giving you the knowledge and understanding essential to create a wider perspective of your role within the industry. Taught by experts from across the pharmaceutical industry, this is your opportunity to understand how each department works together throughout the product development process.
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 5th Annual Congress: Partnering with Central Labs, Cardiology and Imaging Labs Europe
Studies have shown that conducting clinical trials represents an average of 37% of the total cost to bring a new medicinal product to market, and central laboratory testing represents a critical step in supporting the evaluation of a new product. Central lab services have become a crucial component in more than 70% of all clinical trials worldwide, by helping reduce drug development costs and speed up drug development cycle times, it has become more important than ever.
The 5th Annual Congress: Partnering with Central Labs, Caridiology and Imaging Labs Europe has become the most comprehensive event in Europe to focus only on aligning sponsors, central labs, ECG and Imaging labs in collaborative partnerships that aim to improve process efficiencies to advance drug development. This annual congress will address the timely and challenging issues of building strong long-term relationships, data integration and management problems, new and future trends in the central lab industry and outsourcing strategies.
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 Labelling and Packaging Compliance for Medical Devices and In Vitro Diagnostics
Overcome the challenges you face in labelling your medical devices and IVDs with Informa Life Sciences’ 2nd Annual ‘Labelling and Packaging Compliance for Medical Devices and In Vitro Diagnostics’. Dedicated tracks are focused to target your labelling needs.
This event will provide you with the latest information on the harmonisation of symbols’ standards and provide you with the practical knowledge to ensure your labelling is globally compliant. Translation is still a major challenge with ever increasing country demands. This not only means increasing languages competing for space on your labelling but also an increased translation burden. Your expert speakers will provide you with the take home know how to manage your translation strategy.
Major markets now demand bar-coding of your devices and diagnostics. If you do not have the correct barcode then you could be excluded from those markets and lose market share. Automatic identification is coming. Are you prepared for it?
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 Medical Device Law and Compliance
Informa Life Sciences have designed a detailed, in-depth and practical forum to enable you to conduct business without being confronted with potential infringement to legislation. This comprehensive programme enables you to develop your knowledge and competency in medical device regulatory and compliance challenges.
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 6th Annual: Clinical Trial Supplies and Packaging Summit
The clinical supply chain is a complex mechanism, consisting of medical products, patient-related goods and supplies used by service facilities. Timing and accuracy are two of the most important criteria to be considered when managing the supply chain. Indeed, clinical trial supplies must be delivered at the right quantity, right place and right time. Therefore, pharmaceutical companies must concentrate on streamlining the clinical supply chain to maximise efficiencies and protect their own financial well being.
The IIR 6th Annual Clinical Trial Supplies and Packaging Summit has become an established event in the industry, providing each year new solutions to emerging challenges affecting the management of clinical supplies.
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 Legal and Regulatory Strategies for Lifecycle Management
With the recent increase in competition from generics companies and a significant reduction in the number of new innovator products, to ensure a maximum ROI pharmaceutical companies are turning to legal and regulatory strategies to maximise the lifecycle of a product. The strategies available to the indusrty and the regulations and guidance surrounding them however remains unclear.
This conference presents a wide range of strategies that the pharmaceutical industry can use to maximise/extend the lifecycle of their products, allowing companies to develop succesful strategies for managing their product lifecycles.
PLUS:
Hear from Dominik Schnichels talk about the EC sector inquiry and get the opportunity to ask your questions.
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 Market Success through Pricing and Reimbursement
Without European harmonization of reimbursement each country presents its own set of challenges to medical device companies seeking reimbursement for their products. Constant changes/developments in each countries reimbursement systems means that there is a need for one place where medical device companies can gain an summary of the recent changes taking place in the major markets (Germany, France, UK, Spain and Italy).
With an increase in the demand for clinical evidence from the medical device companies there are new challenges as pricing and reimbursement considerations now need to take in the cost impacts of running these clinical trials. A closer relationship between clinical researchers, pricing and reimbursement managers and marketing / sales managers means there is a need for a place where open discussion about the future of this field lies. This years Market Success Through Pricing and Reimbursement provides a forum to hear case studies and regulatory guidance on gaining access to Europes major markets and then discuss with each other the best strategies for success.
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 BioProduction 2008
BioProduction 2008 Conference and Exhibition is the premier event to attend this autumn for a comprehensive update on operational strategies, technologies, regulatory changes, manufacturing production and process development. Develop key relationships and obtain fresh ideas on how to benchmark your best practices. Network with your peers and evaluate new technologies and processes on how to get to market quicker.
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 Drug Delivery Partnerships
DDP is Europe's premier drug delivery conference – a MUST for those working in this industry. As an industry that is extremely partnership-intensive, commercial success requires strategic collaboration, this ideal and dynamic event provides an ideal opportunity to connect with potential partners. Delivering the latest strategies, business models, industry updates and networking functions to help position your company for a successful partnership/collaboration, this event is not to be missed.
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 Drug Device Combination Products
Define the regulatory route for your combination products as early as possible. This is the advice from key industry leaders. However with an ever evolving regulatory environment, how can you ensure you comply with the requirements to acheive rapid market access?
Informa Life Sciences' 3rd annual 'Drug Device Combination Products' provides a unique platform for regulatory authorities, notified bodies and manufacturers to come together to share experiences and challenges.
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 Lifecycle Management of the eCTD
Informa Life Sciences’ 3rd Annual Lifecycle Management of the eCTD conference will show you how to work with the regulators to speed up your submissions and
approvals. Covering all the latest developments, from Product Information
Management to parallel variations, this is the essential meeting for professionals
working in the areas of submission publishing and regulatory affairs.
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 European Biobanking and Biorepositories 2008
The 5th European Biobanking and Biorepositories 2008 (11-12 Nov 08) Autumn meeting highlights include regulatory updates, legal implications, ethical challenges, clever storage solutions, smooth automation services, global IT applications and 7 industry case studies. This meeting has previously been sold out so we advise early booking.
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 Post Translational Modifications (PTMs)
Post Translational Modifications (PTMs) are an important aspect to consider when dealing with Biologics. This event will cover the entire spectrum of the industry with a special emphasis on:
Impact Post Translational Modifications have on biological function
Regulations for dealing with biologics
Alternative expression systems
Cell culture conditions
Cell line development and engineering
Glycoprofilling as an analytical technique
Issue of immunogenicity when dealing with PTMs
Analytical techniques for measuring and characterising PTMs
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 Registration of Generics Summit
Informa Life Sciences' Registration of Generics Summit will provide delegates with practical solutions for successful generic registration submissions.
Our international panel of regulatory and industry speakers will share their experiences with DCP and MRP procedures in Europe; and examine how you can improve your eCTD and lifecycle management programmes. Gain a complete update of the pending revisions to filing variations, PIL-testing and paediatric regulatory requirements.
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 Stability Testing for Biologics
Europe’s ONLY conference dedicated to the stability testing of biological drugs. Join us in Munich to discover how leading industry experts develop their stability programmes to achieve maximum success.
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 Registration of Pharmaceuticals in the EU
Delegates will gain a clear understanding of the current requirements for MA applications in the modular CTD format. Practical exercises will demonstrate the requirements for all parts of the dossier – quality, nonclinical and clinical. Delegates will acquire a good understanding of the changing regulatory requirements and procedures for Active Substance Master Files and Certificates of the European Pharmacopoeia. The use of electronic submissions will also be examined, together with the latest developments in Regulatory Affairs for EU Filings
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 Stability Testing for Pharmaceuticals
Stability testing is an integral part of pharmaceutical development. This conference aims to help you clarify guidelines, gain tips for best practice and find out the latest developments in the field.
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 MEDICAL DEVICE REGULATIONS COURSE
Informa Life Sciences’ ‘Medical Device Regulations’ course takes place on 25 & 26 November 2008 in Amsterdam, The Netherlands. By providing advice on all parts of the regulatory process and how to get your product to market quickly, this event directly responds to industry needs.
Providing introductory theoretical and practical understanding of the processes and practices central to medical device regulatory affairs, this course provides detailed insight into current and proposed legislation in the area and education in the processes and practices require for its implementation.
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 Vaccines Europe
New for 2008: Announcing the launch of Vaccines Europe, where you can meet and network with professionals from across all areas of the vaccines industry. Pay just one price to attend any talk from any of the 3 conferences:
Vaccine Discovery and Development
Vaccine Characterisation and Quality Control
Vaccine Scale-Up and Manufacturing
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 Electro-Medical Devices: Design, Regulations and Safety
Looking to gain compliance with the 3rd edition? Wondering if medical devices will be included into the RoHS directive? Need an update on directives affecting electro-medical devices?
This conference provides a forum for you to do gain clarity on the latest standards, regulations and legislations (i.e. 60601, RoHS, REACH, battery directive, labelling requirements etc), provides opportunities for you to benchmark your compliance strategies and have your questions answered by leading industry experts.
Download the brochure to view the full agenda
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 Preclinical and clinical safety testing for new drugs
On the 2nd and 3rd of December 2008, Informa will hold the 2nd Annual Preclinical and clinical safety testing for new drugs conference in Basel, Switzerland.
This year attendees willl gain a balanced look at safety testing in target organs, from the liver to the CNS, including topics such as ‘reactive metabolites as a preclinical warning for idiosyncratic liver toxicities’ and ‘whats missing from your pre-clinical toolkit to more accurately predict QT risk’.
With new regulations and guidelines from the FDA, EMEA and ICH defining the way the industry will have to perform your safety tests, we will ensure delegates will have the chance to hear from the regulators, including the MHRA, about what they expect from their safety reports and what plans they’ll need to put in place to be compliant.
Finally, improve the predictability of your safety tests by attending sessions on improving study designs for your first in man trials, and how to select the right animal model for your preclinical study.
This year be sure to attend 'Preclinical and clinical safety tests for new drugs' to improve the predictability of your pre-clinical safety tests and ensure efficient translation from the pre-clinical to clinical stage.
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 Process Validation and Verification for Medical Devices
Process Validation and Verification for Medical Devices
Benchmark your strategy to plan and implement a successful validation programme
2 – 3 December 2008, EXCELSIOR HOTEL ERNST, Cologne, Germany
Co-located with Sterilization for Medical Devices
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 Sterilisation for Medical Devices
The revised standards for sterilisation have caused waves of change in your processes – are you confident in interpreting the revisions? With industry hotly anticipating the publication of ISO 11135:2 and ISO 10993:7 in the autumn, what impact will these have on your processes and how can you ensure that you are compliant?
Informa Life Sciences' 2nd annual 'Sterilisation for Medical Devices' meeting in Cologne will provide you with the know-how you need to successfully implement the standards in your business. Join us to explore the main methods of sterilisation used by medical device manufacturers, namely ethylene oxide, radiation and moist heat, in just 2 days.
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 Signal Detection and Risk Management
This event covers various aspects of signal detection in the pharmaceutical and biotech industries, including quantitative and qualitative analysis, data mining and regulatory insights. It also looks at risk management and the development of the risk management plan, the EU RMP template, how to compile this for various types of drugs and regulatory insights.
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 Strategies to Enhance Solubility and Drug Absorption
This international expert forum will discuss all the latest approaches to improving solubility, permability and bioavailabiliy of drugs. Delegates will get an excellent chance to learn, network and benchmark their own practices.
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 Forced Degradation Studies
Forced Degradation studies are performed during development and stability testing of pharmaceuticals and biopharmaceuticals. They are used in determining the degradation pathways of products and being able to identify when products produce harmful degradants or have an unsuitable shelf life.
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