Events & Training for December 2009

Clinically relevant Drug Transporters

30 November 2009 - 02 December 2009

Mövenpick Hotel Berlin, Berlin, Germany

European Antibody Congress 2009

30 November 2009 - 02 December 2009

Crowne Plaza Hotel, Geneva, Switzerland

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

CPhi India 2009

01 December 2009 - 03 December 2009

Bombay Exhibition Centre, Mumbai, India

Biosimilars India 2009

01 December 2009 - 02 December 2009

Bombay Exhibition Centre, Mumbai, India

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

Informa Life Sciences 10th Annual EuroTides 2009

02 December 2009 - 03 December 2009

Holiday Inn Lijnden Schiphol, Amsterdam, Netherlands

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

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

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

Dermatological Advances

03 December 2009 - 04 December 2009

BSG House, London, UK

The Role of Natural Products in Drug Discovery in Drug

04 December 2009

Royal Pharmaceutical Society of Great Britain, London, UK

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

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

Exploratory Clinical Trials 2009

08 December 2009 - 09 December 2009

Brussels, Belgium

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

Drug Delivery to the Lungs - DDL20

09 December 2009 - 11 December 2009

The Edinburgh International Conference Centre, The Exchange, Edinburgh EH3 8EE, Scotland, UK

The Society for Medicines Research Conference on: "Recent Disclosures of Clinical Candidates".

10 December 2009

National Heart & Lung Institute, Kensington, London

Genesis 2009 The Leading Biotechnology Partnering Conference

10 December 2009 - 11 December 2009

QE II Conference Centre, London, United Kingdom

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

First International Conference on Metal Chelation in Biology and Medicine

11 December 2009 - 14 December 2009

University of Bath, Bath, UK

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