R&D

Upcoming

2011

TBA 2 - Day Course	Developing methods of isolation and identification Lecturer: Mr. Igal Gozlan
TBA 2 - Day Course	Quantitative Analysis by LC–MS Lecturer: Dr. Wilfried Niessen
	One of the most important applications of LC–MS is its use in routine quantitative analysis, in preclinical and clinical studies to sustain drug development, and in food safety and environmental analysis. This two-day course pays specific attention to aspects related to quantitative analysis by LC–MS for pharmaceutical applications as well as quantitative (multi)residue analysis by LC–MS for environmental and food-safety applications.
TBA 3 - Day Course	Statistical Analysis of the Composition and Homogeneity of Mixtures Lecturer: Dr. Evgeny Tartakovsky
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.
TBA 2 - Day Course	Creating and Managing an Intranet Portal as a Knowledge Mangement Tool Lecturer: Dr. Nava Rotem
TBA 2 - Day Course	Process Scale-Up - Advanced Level Lecturer: Ariel Ewenson
TBA Day Course	Structure Based in Silico Driven Drug Optimization Lecturer: Dr. Elad Segev
TBA Day Course	Introduction to Bioassay for Non-Biologists Lecturer: Dr. Ana Menendez, USA
TBA Day Course	Analitical Solutions in GC-MS Lecturer: Dr. Igal Bar-Ilan

2010

12/09/2010 2 - Day Course	Retrieving Compound Identity Using LC–MS–MS Lecturer: Dr. Wilfried Niessen
	This two-day course provides knowledge for structure elucidation of small molecules (drugs, pesticides, natural products, etc.) by combined liquid chromatography–tandem mass spectrometry (LC–MS–MS). We study the fragmentation of positively and negatively charged even-electron ions in MS–MS, and discuss identification strategies, both from data-acquisition and from data-processing point of view. Next to lectures and time for questions and discussion, the Course provides exercises in order to practice spectral interpretation.
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.
01/11/2010 Day Course	How to Design and Write Protocols for Clinical Trials Lecturer: Dr. Dan Goldstaub
08/11/2010 2 - Day Course	Project Management and Change Control Lecturer: Ms. Karen Ginsbury
10/11/2010 Day Course	Extractables and Leachables from containers/closures of drugs and from devices Lecturer: Dr. Raphy Bar
	This course will give participants an understanding of how chemicals leached from containers and closures of pharmaceutical and biopharmaceutical drugs as well as from medical devices, are detected and quantified in the framework of a properly designed Extractables/Leachables (E&L) study. Examples of E&L will be presented.
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.
16/11/2010 Day Course	Polymorphism in the Pharmaceutical Industry Lecturer: Dr. Judith Aronhime
16/11/2010 3 - Day Course	Stabilization of Proteins and Peptides along the Formulation Process Lecturer: Dr. Mark Cornell Manning
17/11/2010 3 - Day Course	DOE - Design Of Experiments Lecturer: Dr. Evgeny Tartakovsky
23/11/2010 Day Course	Polymers in design of drug delivery systems Lecturer: Dr. Adel Penhasi
29/11/2010 Day Course	Development of Therapeutic Monoclonal Antibodies Lecturer: Dr Judith Ben Porat
16/12/2010 Day Course	Fundamentals to Design Strategic Immunogenicity Programs Lecturer: Dr. Ana Menendez, USA
19/12/2010 2 - Day Course	Dissolution Testing Lecturer: Dr Malcolm Ross
	The course looks at the history of the dissolution test in order to understand how we have arrived at today’s situation. It will review the test methods, both official and unofficial and discuss the development and validation of dissolution tests.
22/12/2010 2 - Day Course	Analytical Data Serving the QA, Regulatory & Formulation Staff Lecturer: Dr Malcolm Ross
	Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory.

Past Activities

2010

22/06/2010 6 - Day Course	Professional Qualification of R&D Personnel for the Generic Drug Industries Professional management: Dr. Sigalit Arieli-Portnoy
TBA Day Course	Endotoxin Testing in Drugs and Medical Devices – the Basics Lecturer: Mr. Eliezer Solomon
02/06/2010 3 - Day Course	Troubleshooting and Solving Problems in HPLC - Advanced Lecturer: Dr. Shulamit Levin
	Especially the experienced chemists might find be surprised
12/05/2010 Day Course	Analysis & Charaterization of Polymorphs in the Pharmaceutical industry Lecturer: Dr. Judith Aronhime
29/04/2010 Day Course	Technology Transfer of Analytical Methods Lecturer: Dr. Raphy Bar
	Analytical methods once validated, are often transferred and implemented in other laboratories. Thus, methods can be transferred from an R&D lab to a QC lab in the same or different site, or to an external CRO lab.
28/04/2010 Day Course	Phase Appropriate GMP for Investigational Products Lecturer: Ms. Karen Ginsbury
28/04/2010 3 - Day Course	Bio-chemometrics: Elementary statistics Lecturer: Dr. Evgeny Tartakovsky
	This three-day course presents in a systematic manner the basic principles of chemometrics in the context of bio-analytical, analytical chemistry as well as of R&D activities. The course comprises a large number of real-life examples and exercises.
26/04/2010 Day Course	Atomic Absorption – AA Lecturer: Dr. Yaakov Tabak
22/03/2010 Day Course	Conducting, Documenting and Ensuring Effective Investigations Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
	At the end of this course participants will understand how to effectively investigate deviations and untoward events.
21/03/2010 2 - Day Course	Formulation for Chemists Lecturer: Dr Malcolm Ross
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
08/03/2010 2 - Day Course	Validation of analytical methods in compliance with FDA/ICH/USP guidance - ADVANCED-LEVEL COURSE Lecturer: Dr. Raphy Bar
	This advanced course is aimed at teaching the various performance characteristics of analytical methods while providing the participant with a deeper insight and understanding of the design and implementation of these validation parameters.
TBA 2 - Day Course	Strategic and Risk Management in a Drug Development Lecturer: Dr. Yitzchak Angel
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	Enhancing Laboratory Efficiency , a Course for Managers Lecturer: Dr. Sigalit Arieli-Portnoy
17/01/2010 Day Course	Gel Permeation Chromatrography (GPC) Systems in Pharmaceutical Applications Lecturer: Dr. Mark Pothecary, UK

2009

09/12/2009 2 - Day Course	Technology Transfer Lecturer: Dr Malcolm Ross, Switzerland
12/11/2009 Day Course	Liposome Applications Professional management: Dr. Doron Friedman
	This comprehensive course is designed to bring together several aspects of the subject. This includes design, fabrication and basic science which are all critical to the above including physics and chemistry and clinical development, toxicology aspects, case studies and I.P. issues.
20/10/2009 Day Course	Pharmaceutical Polymers Lecturer: Dr. Adel Penhasi
TBA Day Course	Product Control Strategy – Integrating Risk Management into Product Development Lecturer: Ms. Karen Ginsbury
08/06/2009 Day Course	Statistical Criteria for Validation of Analytical Methods Lecturer: Dr. Raphy Bar
	Validation of analytical methods is a common regulatory requirement. Yet, it is a process that is carried out at various levels at different laboratories. However, there is no doubt that a statistical treatment of the validation data brings scientific rigorousness to the experiments and renders the validation report more reliable and more easily acceptable to regulatory agencies. This advanced course concentrates directly on the acceptance criteria of the various performance characteristics of analytical methods and on the statistical tests that answer these criteria.
03/06/2009 2 - Day Course	Analytical Chemistry for non-analytical chemists Lecturer: Dr Malcolm Ross, Switzerland
	Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory.
31/05/2009 2 - Day Course	Dissolution Testing Lecturer: Dr. Malcolm Ross, Switzerland
	The course looks at the history of the dissolution test in order to understand how we have arrived at today’s situation. It will review the test methods, both official and unofficial and discuss the development and validation of dissolution tests.
TBA 6 - Day Course	Professional Qualification of R&D Personnel for the Generic Drug Industries Lecturer: Dr. Sigalit Arieli-Portnoy
25/05/2009 2 - Day Course	Managing Extractables and Leachables in Pharmaceutical Products Lecturer: Ph.D. Edward J. Smith
	This course will review guidance documents, and other regulations regarding the identification, measurement, toxicological qualification, and reporting of extractables/leachables from packaging and process materials into pharmaceutical and biotech products. Included in the course is a detailed discussion of the sources of extractables from glass, rubber, and plastic packaging and process components and the work of the Product Quality Research Institute (PQRI) on inhalation, ophthalmic, and parenteral products. Examples will also be presented to demonstrate how E&L issues can be mitigated through the judicious choice of packaging components and materials.
27/01/2009 Day Course	Particle & Material Characterization :
	The one day seminar will provide a basic and practical overview of Particle size and distribution, shape, rheology, dispersion stability and how these various material properties can be linked together and used in conjunction with each other for enhanced product understanding.
22/01/2009 Day Course	Chiral Recognition and Separation Mechanisms Lecturer: Prof. Nelu Grinberg, USA
	The course will focus on specific interactions between the enantiomeric analytes and each specific chiral stationary phase, rather than the techniques used to separate enantiomers. This approach will allow the participants to understand the strategies for development of a separation of enantiomers, along with the conditions to achieve each type of interaction.