Pre-clinical

Upcoming

2011

TBA 2 - Day Course	Biocompatibility Evaluation of Medical Device & Biomaterials Lecturer: Dr. Shayne Gad
	The goal of this course is to enable you to develop new medical devices faster, more efficiently and with less expense by giving you a practical working knowledge of biocompatibility and device development.
TBA 3 - Day Course	Non-Clinical Drug Safety Evaluation and Drug Development Lecturer: Dr. Shayne Gad
	This course provides a comprehensive explanation of the non-clinical development of drugs, biologics and combination products, emphasizing the principles of pharmaceutical toxicology and the assessment of product safety. In addition to the different types of toxicity studies in modern pharmaceutical development, it also describes the relationship between pharmacology, clinical trial design, regulatory strategy and project management.

2010

01/11/2010 Day Course	Pharmacokinetics and Pharmacodynamics - Basic Principles Lecturer: Prof. Roni Levy
	Pharmacokinetic (PK) and pharmacodynamic (PD) parameters play a major role both at the design stage and at the analysis stage of preclinical and clinical studies. The fundamental parameters of PK and PD will be discussed at this full day course, as well as their relationships. In order to use these parameters at the design and analysis stages of the studies – the related mathematical equations will be presented and their correct use will be explained. The course will reinforce the knowledge of researchers, developers, quality assurance and regulation staff, and expand their ability to use this important information in their assignments. The course will be accompanied by demonstration of the use of the various parameters in the solution of problems.
15/11/2010 2 - Day Course	GLP Lecturer: Dr. Oded Laor
	GLP is a reliable set of practices which can help you with the quality and comprehensiveness of your data and conclusions in Pre-clinical trials, as well as efficient management of laboratories.
14/12/2010 2 - Day Course	Development and Validation of Bioassays Lecturer: Dr. Ana Menendez, USA
	The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.

Past Activities

2010

TBA Day Course	Toxicology:From Biopsy to Histological Diagnosis – Histology, Histochemistry, Image Processing and Quantification Lecturer: Dr. Tamar Kadar
	Toxicology:From Biopsy to Histological Diagnosis – Histology, Histochemistry, Image Processing and Quantification
TBA 2 - Day Course	Drug Safety Lecturer: Ms. Orit Neudorfer
	This course will review the history of drug safety until present days, and describe how safety management has changed its scope to achieve its new challenges. Development of safety strategy, from early development, throughout clinical phases until post-marketing, will be studied, including the establishment of an effective risk management plan.
24/02/2010 Day Course	Pharmacokinetic (PK) and pharmacodynamic (PD) considerations Lecturer: Prof. Roni Levy
	Pharmacokinetic (PK) and pharmacodynamic (PD) considerations are closely involved in the development stages of drugs, and their correct implementation in preclinical and clinical trials is vital for the success of the development process. This full day course will be devoted to practical aspects of the subject, using illustrations and tutored solution of problems.

2009

13/07/2009 2 - Day Course	Development and Validation of Bioassays Lecturer: Dr. Ana Menendez, USA
	The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.
05/07/2009 2 - Day Course	Preparing Protocols & Final Reports for Clinical Trial Lecturer: Dr. Shayne Gad
TBA Day Course	GMP / GCP / GLP – The overlap in preparation of material for Preclinical and Clinical Trials Lecturer: Ms. Karen Ginsbury

2008

TBA Day Course	Toxicology:From Biopsy to Histological Diagnosis – Histology, Histochemistry, Image Processing and Quantification Lecturer: Dr. Tamar Kadar
	The course will focus on fixation methods, dyes, light microscopes, fluorescence microscopes, immunohistochemistry, FISH, computerized quantitative analysis using image processing software, and principles in electronic microscopy.

2007

29/10/2007 2 - Day Course	Development and Validation of Bioassays Lecturer: Dr. Ana Menendez, USA
	The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.

2006