Biotechnology

Upcoming

2011

TBA 2 - Day Course	Marketing Authorization of Biologicals in the EU Lecturer: Dr. Barbara Jentges
	This course focuses on the legislative environment regulating biologicals within the European Union and gives an understanding of the regulatory steps that need to be taken to successfully place a biological on the European market.
TBA Day Course	Introduction to Bioassay for Non-Biologists Lecturer: Dr. Ana Menendez, USA
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

2010

14/09/2010 Day Course	Color Testing Lecturer: Dr. Yehuda Shekel
24/10/2010 Day Course	Biosensors: Priciples & Applications Lecturer: Dr Ronen Almog
08/11/2010 2 - Day Course	Building eCTD-compliant Documents and Preparing an eCTD Submission Lecturer: Dr. Barbara Jentges
	This course will give an understanding for ‘eCTD’ and the differing regional requirements. Aspects for the preparation of ‘eCTD-compliant’ documents will be discussed in detail during practical examples.
09/11/2010 3 - Day Course	Process Validation Lecturer: Dr. Eli Schmell
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
30/11/2010 2 - Day Course	Rapid Microbiological Methods - RMM Lecturer: Dr. Michael Miller
05/12/2010 Meeting	Flow Cytometer – FACS Lecturer: Dr. George Shubinsky
16/12/2010 Day Course	Fundamentals to Design Strategic Immunogenicity Programs Lecturer: Dr. Ana Menendez, USA

Past Activities

2010

23/06/2010 3 - Day Course	Regulatory and Quality requirements for the registration of Biologics/Biotechnology Products Lecturer: Rivka Zaibel
16/06/2010 2 - Day Course	Development of Combination Products - Regulatory & Clinical Considerations Lecturer: Dr. Barbara Fant
TBA 2 - Day Course	Strategic and Risk Management in a Drug Development Lecturer: Dr. Yitzchak Angel
16/02/2010 2 - Day Course	Water Systems in the Pharmaceutical & Biotechnological Industries Lecturer:

2009

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.
TBA 2 - Day Course	Registration of Biosimilars in the European Union Lecturer: Dr. Barbara Jentges
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.

2008

2007

30/11/2007 Day Course	Bioassay Development and Validation Lecturer: Dr. David Lansky, USA
	This two day course covers the fundamental concepts needed to understand bioassay, bioassay development, validation of bioassays, setting specifications for bioassays, and setting product specifications based on bioassay measurements.

2006