EMEA Joint Meeting with TOPRA: Evolution to the next Step– The Needs of the Future?
01 December 2009 - 02 December 2009
The 4th annual EMEA round-up of the year and look towards the next year - a firm favourite with many European regulatory affairs personnel as the key year-end event to reflect on the year gone by and to plan for the upcoming year.
East Wintergarden, Canary Wharf, London, UK
http://www.topra.org/emea2009
Cold Chain Distribution
02 December 2009 - 03 December 2009
The dangers associated with temperature sensitive products going out of range are well documented and serious - this conference will help you to avoid these unnecessary costs.
The conference will be covering a wide range of topics, including:
Managing costs in the face of rising energy prices
Enhancing packaging
Temperature logging
Environmental sustainability
Risk assessments for efficiency
Ambient temperature storage and transport
Marriott Regents Park, London, UK
http://www.smi-online.co.uk/events/overview.asp?is=4&ref=3174
Pre-clinical and Clinical Safety Testing for New Drugs
02 December 2009 - 03 December 2009
Making better 'go/no-go' decisions whilst ensuring regulatory compliance.
Swisshotel Le Plaza, Basel, Switzerland
http://www.informa-ls.com/drugsafety
An Introduction to Immunogenicity
02 December 2009 - 03 December 2009
Performance & knowledge objectives of this course:
Understand the basic principles behind immunogenicity
Detect, minimise, and identify the root cause of protein immunogenicity as early as possible
Discuss the advantages/disadvantages of various assay platforms used to detect and characterise unwanted immunogenicity
Appreciate the impact of immunogenicity on PK, efficacy, and safety
Interpret the latest EU and US regulatory guidelines
.Discover successful strategies for validating immunogenicity assays for both pre-clinical and clinical studies
Regus Victoria, London, UK
http://www.iir-events.com/IIR-conf/PTI/EventView.aspx?EventID=1371&SearchResult=http%3a%2f%2fwww.iir-events.com%2fIIR-conf%2fPTI%2fSearchEvents.aspx
Comparability for Biologics
03 December 2009 - 04 August 2009
Process changes made during the manufacture of recombinant proteins can have profound implications. This 2-day practical course provides valuable insight into the quality, safety, efficacy and regulatory impact of manufacturing changes. Delegates will also learn how to manage process change to ensure regulatory compliance and product consistency at all times.
Key performance objectives of this course:
Gain insight into the inter-relationship between process change, quality, safety and efficacy
Examine the importance of change control, Good Manufacturing Practice (GMP) and the potential of Process Analytical Technology (PAT)
Discuss the potential significance of various process changes and how these may impact the quality of your products
Understand the physicochemical and biological tools available to monitor the impact of process change
Analyse the US and EU regulatory requirements following process change
Regus Victoria, London, UK
http://www.iir-events.com/IIR-conf/PTI/EventView.aspx?EventID=1316&SearchResult=http%3a%2f%2fwww.iir-events.com%2fIIR-conf%2fPTI%2fSearchEvents.aspx
Antibody Engineering
06 December 2009 - 10 December 2009
The 2009 program couples scientific content showcasing basic science research developments with presentations on the progression of industry antibody-based drug products into and through clinical development.
Sheraton San Diego Hotel and Marina, CA USA
http://www.IBCLifeSciences.com/antibodyeng
2nd Annual Developments in Drug Safety
07 December 2009 - 08 December 2009
Hear from industry experts on best practices for completing REMS
Learn about new developments and how to prepare for them now
Learn how to incorporate safety measures at every step of the development process
Prepare yourself by learning from tried and tested methods of drug safety
Grand Hyatt, Washington DC, USA
http://www.exlpharma.rsvp1.com/eventDetail.php?id=207
Antibody Therapeutics
08 December 2009 - 10 December 2009
Antibody Therapeutics Session for 2009 includes new presentations on:
Business, Regulatory and Intellectual Property
Clinical Development for Cancer
Clinical Development: Alzheimer's and Others
Clinical Development: Autoimmune Diseases
Clinical Development: Inflammation and Infection
Preclinical Development of Antibody Therapeutics
Sheraton San Diego Hotel and Marina, CA, USA
http://www.ibclifesciences.com/antibodyeng/overview.xml
Drug Delivery to the Lungs - DDL20
09 December 2009 - 11 December 2009
The Edinburgh International Conference Centre, The Exchange, Edinburgh EH3 8EE, Scotland, UK
http://ddl-conference.org.uk/
The Society for Medicines Research Conference on: "Recent Disclosures of Clinical Candidates".
10 December 2009
National Heart & Lung Institute, Kensington, London
http://www.smr.org.uk
Genesis 2009 The Leading Biotechnology Partnering Conference
10 December 2009 - 11 December 2009
QE II Conference Centre, London, United Kingdom
http://www.genesisconference.com/
2nd DIA Conference for Harmonization of Risk Management Plans
10 December 2009 - 11 December 2009
This conference will teach you how to identify and organize essential components of an RMP vis-á-vis well-described risks, poorly understood risks, and certain potential risks of products, which may be made available to patients and healthcare providers in different regions of the world. It includes hands-on exercises in addition to didactic presentations, interactive examples, and panel discussions.
Washington Marriott Hotel 1221 22nd Street NW Washington, DC 20037-1294
http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=21302&eventType=Meeting
Developing Personalised Cancer Therapies
11 December 2009
In this master class a general introduction into designing trials with personalised cancer treatments will be provided. Background information will be given on pharmacogenetics, pharmacogenomics, targeted therapies, biomarker development and patient enrichment. Ideally trials based on personalized cancer treatment should include patients that are most likely to respond and exclude patients that are pre-disposed to toxicity. Best practices in contemporary development of targeted anti-cancer agents will be highlighted. This will result in a discussion about optimizing designs for trials with new agents, finding the best dosing regimens en selection the correct subpopulation to include in “enriched” studies. Finally, some future diagnostics methods (e.g. based on genetic profiling) will be presented.
London, UK
http://www.smi-online.co.uk/training/overview.asp?is=4&ref=3319