Pharmaceutical/Biologics

Upcoming

2011

TBA Day Course	Israeli Legislation on the Quality of Drugs and Biologics Lecturers: Dr. Rachel Karpel, Adv. Yoel Lifshitz
TBA Day Course	Structure Based in Silico Driven Drug Optimization Lecturer: Dr. Elad Segev
22/05/2011 3 - Day Course	Role, Responsibilities and Activities of the Qualified Person in the European Union Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner
25/05/2011 Day Course	The Role of the Qualified Person (QP) of Pharmaceutical and Veterinary Manufacturers and Importers in Israel Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner
26/05/2011 Day Course	Writing and Understanding Technical Agreements Lecturers: Dr Christopher Burgess, Mr. Richard Bonner

2010

12/10/2010 Day Course	Introduction to production of solid dosage forms Lecturer: Mr. Eran Yona
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.
02/11/2010 6 - Day Course	Registration in Israel - Drugs, Biologics, Medical Devices and Cosmetics Professional management: Mgr. Efrat Strugo
02/11/2010 Day Course	בדיקת אנדוטוקסינים בתרופות ואביזרים רפואיים (אמ"ר) המוזרקים / מושתלים בגוף Lecturer: Mr. Eliezer Solomon
16/11/2010 Day Course	Polymorphism in the Pharmaceutical Industry Lecturer: Dr. Judith Aronhime
22/11/2010 2 - Day Course	MedDRA® : A Comprehensive Training Course Lecturer: Dr Elliot Brown
22/11/2010 2 - Day Course	Solid Dosage Manufacturing Process Lecturer: Mr. Michael Tousey, USA
23/11/2010 Day Course	Polymers in design of drug delivery systems Lecturer: Dr. Adel Penhasi
24/11/2010 Day Course	Analytical Standards in Pharmaceutical & Bio-pharmaceutical Laboratories: Qualification of Primary & Secondary Standard Lecturer: Dr. Raphy Bar
24/11/2010 Day Course	Tablet Pro Lecturer: Mr. Michael Tousey, USA
	Tablet Pro (Professional) is a one day comprehensive course covering tablet press operations. The participant will gain a complete understanding of the importance of tablet press set-up, machine function, operation, and cleaning.
30/11/2010 2 - Day Course	Rapid Microbiological Methods - RMM Lecturer: Dr. Michael Miller
TBA 2 - Day Course	Risk Management Throughout a Drug Lifecycle Lecturer: Dr Stanley Garbus
	The course is based on the risk (risk/benefit assessment) for prescription drug products but the concept of Risk Management and Mitigation is universal and being recognized by regulatory authorities as necessary for devices and biotech products as well.
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.
21/12/2010 2 - Day Course	A deep Insight into Pharmacovigilance and Risk Management Regulatory Systems, advanced level Lecturer: Dr. Irene Fermont
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.
27/12/2010 2 - Day Course	Optimizing the Drug Development Process using PK/PD Modeling Lecturer: Dr. Serge Guzy, USA

Past Activities

2010

27/07/2010 Day Course	Impurities in Active Pharmaceutical Ingredients (APIs) and in Pharmaceutical Products Lecturer: Dr. Rachel Karpel
	Impurities in Active Pharmaceutical Ingredients (APIs) and in Pharmaceutical Products
22/06/2010 6 - Day Course	Professional Qualification of R&D Personnel for the Generic Drug Industries Professional management: Dr. Sigalit Arieli-Portnoy
16/06/2010 2 - Day Course	Development of Combination Products - Regulatory & Clinical Considerations Lecturer: Dr. Barbara Fant
TBA Day Course	Endotoxin Testing in Drugs and Medical Devices – the Basics Lecturer: Mr. Eliezer Solomon
13/05/2010 Day Course	ICH, EMEA and FDA Guidelines for Drug and Drug-Substances Stability Lecturer: Dr. Rachel Karpel
12/05/2010 Day Course	Analysis & Charaterization of Polymorphs in the Pharmaceutical industry Lecturer: Dr. Judith Aronhime
04/05/2010 Day Course	Pharmacopoeias and Compendial Testing of Pharmaceuticals Lecturer: Dr. Raphy Bar
	US and European pharmacopoeias are independent organizations that set the standards for determining the quality of pharmaceutical products marketed in the US or Europe. These standards govern the quality, strength, purity and potency of active pharmaceutical ingredients, dosage forms and excipients as well as many reagents and solutions used to test these materials. USP and Ph.Eur. are legally recognized compendia for regulatory agencies and they are widely used by the pharmaceutical industry. Any pharmaceutical testing laboratory must be capable of applying the tests described in the compendial monographs.
04/05/2010 Day Course	Cost Effective Manufacturing in tablet production Lecturer: Mr. Michael Tousey
28/04/2010 Day Course	Phase Appropriate GMP for Investigational Products Lecturer: Ms. Karen Ginsbury
TBA 4 - Day Course	Quality in Registration Files Lecturer: Dr. Rachel Karpel
21/03/2010 2 - Day Course	Formulation for Chemists Lecturer: Dr Malcolm Ross
17/03/2010 Day Course	The Israeli Regulation for Pharmacology – Updates Lecturers: Mgr. Naomi Shaco Ezra, Adv. Zohar Yahalom
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	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	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.
16/02/2010 2 - Day Course	Water Systems in the Pharmaceutical & Biotechnological Industries Lecturer:
17/01/2010 Day Course	Gel Permeation Chromatrography (GPC) Systems in Pharmaceutical Applications Lecturer: Dr. Mark Pothecary, UK

2009

22/12/2009 2 - Day Course	Planning and performing internal audits according to the GMP Lecturer: Dr. Orna Dreazen
	Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization.
TBA 2 - Day Course	Powder Technology - The Missing Link in Solid Dosage Formulation Lecturer: Dr. Malcolm Ross, Switzerland
	The course will concentrate on solid dosage forms but some mention will be made of other dosage form designs where particle size is critical.
09/12/2009 2 - Day Course	Technology Transfer Lecturer: Dr Malcolm Ross, Switzerland
02/12/2009 2 - Day Course	Film Coating Lecturer: Dr. Stuart Porter
	This course is intended for scientists responsible for the development of film-coated oral solid dosage forms, and scientist, engineers, operators and supervisors responsible for providing technical support with respect to film-coated products.
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
14/09/2009 Day Course	Introduction to production of solid dosage forms Lecturer: Mr. Eran Yona
07/07/2009 Day Course	Academic and Industrial Views on the Development of Lipid Based Drug Delivery Systems to Address Oral Bioavailability Challenges Lecturers: Eduardo Jule, Dr. David Edwards, Prof. Meir Shinitzky , Prof. Shimon Benita
06/07/2009 Day Course	Validation of USP / EP Sterility Test Lecturer: Mr. Alexander Gulkarov
01/07/2009 Day Course	Analytical Standards in Pharmaceutical & Bio-pharmaceutical Laboratories: Qualification of Primary & Secondary Standard Lecturer: Dr. Raphy Bar
TBA Day Course	Documenting Clinical Trials Lecturer: Dr. Monica Tocchi
	Writing for and about clinical research in human subjects demands special attention to rules. Learn how to write clear and complete documentation of clinical trials. Effective clinical dossiers are approved more quickly, facilitate protocol compliance and enhance trial quality. This ultimately leads to optimal product labeling, allowing successful marketing and maximization of advertising claims.
22/06/2009 6 - Day Course	Registration in Israel - Drugs, Biologics, Medical Devices and Cosmetics Professional management: Mgr. Efrat Strugo
TBA Day Course	Contamination in Drugs and Drug Substances – Updated Regulatory Requirements Lecturer: Dr. Rachel Karpel
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.
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.
TBA Day Course	Pharmacopoeias and Compendial Testing of Pharmaceuticals Lecturer: Dr. Raphy Bar
	US and European pharmacopoeias are independent organizations that set the standards for determining the quality of pharmaceutical products marketed in the US or Europe. These standards govern the quality, strength, purity and potency of active pharmaceutical ingredients, dosage forms and excipients as well as many reagents and solutions used to test these materials. USP and Ph.Eur. are legally recognized compendia for regulatory agencies and they are widely used by the pharmaceutical industry. Any pharmaceutical testing laboratory must be capable of applying the tests described in the compendial monographs.
TBA Day Course	Israeli Legislation on the Quality of Drugs and Biologics Lecturers: Dr. Rachel Karpel, Adv. Yoel Lifshitz
17/03/2009 Day Course	Supply Chain Risk Management – an Interactive Workshop Professional management: Mr. David Inbar
TBA Day Course	ICH, EMEA and FDA Guidelines for Drug and Drug-Substances Stability Lecturer: Dr. Rachel Karpel
TBA 6 - Day Course	Drug development - strategy and principles Lecturer: Dr. Yitzchak Angel

2008

17/12/2008 Day Course	GMPs in the Manufacture of Clinical Trials Material Lecturer: Ms. Karen Ginsbury
	In July 2008, FDA released a final guidance along with a final rule exempting pharmaceutical manufacturers from the provisions of 21CFR part 211 – GMPs for Finished Pharmaceuticals if manufacturing material for use solely in phase I studies. The EU on the other hand has passed legislation requiring batch release and certification of any investigational medicinal product by a Qualified Person. This course will review the new FDA guidance comparing and contrasting it with the EU GMP requirements in Annex 13.
11/12/2008 Day Course	Polymorphism in the Pharmaceutical Industry Lecturer: Dr. Judith Aronhime
TBA 2 - Day Course	Drug Safety Lecturer: Orit Neudorfer, MD
	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.
30/10/2008 Day Course	Polymers in design of drug delivery systems Lecturer: Dr. Adel Penhasi
16/09/2008 2 - Day Course	Planning and performing internal audits according to the GMP Lecturer: Dr. Orna Dreazen
	Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization.
15/07/2008 2 - Day Course	Tablet Process Development and Quality by Design Lecturer: Dr Michael Gamlen, UK
	The course includes a review of all key tablet manufacturing processes and their critical parameters with special emphasis on blending, in-process testing, and granulation. All participants take part in an interactive workshop on the principles and application of Quality by Design and Process Analytical Technology (PAT).
10/07/2008 Day Course	Evaluation of Stability Data of Pharmaceuticals and Determination of Shelf Life Lecturer: Dr. Raphy Bar
	The ultimate goal of stability storage program is to propose a scientifically sound shelf-life. Regulatory agencies require that it be based on the intersection point between the specification line and the 95% confidence limit curve derived from regression analysis of the stability data.
07/07/2008 2 - Day Course	Technology Transfer Lecturer: Dr. Malcolm Ross, Switzerland
TBA 6 Meetings	Accelerated Drug Development - Risk Management Strategies Lecturer: Dr. Yitzchak Angel
17/06/2008 Day Course	דה-פירוגנציה Lecturer: Mr. Eliezer Solomon
04/06/2008 2 - Day Course	Powder Technology - The Missing Link Lecturer: Dr. Malcolm Ross, Switzerland
	The course will concentrate on solid dosage forms but some mention will be made of other dosage form designs where particle size is critical.
26/02/2008 2 - Day Course	Film Coating Lecturer: Dr. Stuart Porter
	This course is intended for scientists responsible for the development of film-coated oral solid dosage forms, and scientist, engineers, operators and supervisors responsible for providing technical support with respect to film-coated products.

2007

17/12/2007 2 - Day Course	DISSOLUTION TESTING Lecturer: Dr. Malcolm Ross, Switzerland
28/05/2007 Day Course	Polymorphism in the Pharmaceutical Industry Lecturer: Dr. Judith Aronhime
25/04/2007 Day Course	Pharmacopoeias and Compendial Testing of Pharmaceuticals Lecturer: Dr. Raphy Bar

2006

22/05/2006 Day Course	Protein structure: a Basis for Developing Protein Therapeutic Drugs Lecturer: Mr. David C. Carr, USA
22/05/2006 Day Course	The role of Proteomics in the research of Diseases & in Drug Discovery Lecturer: Mr. David C. Carr, USA
26/03/2006 2 - Day Course	Film Coating Lecturer: Dr. Stuart Porter, Dr. Gadi Ben Meir