Clinical Trials

Upcoming

2011

TBA Day Course	Sample Size Calculation Lecturer: Mr Gil Harari

2010

20/09/2010 Day Course	CRF design workshop Lecturer: Ms. Tali Azulay
10/10/2010 7 - Day Course	Qualification of CRA - Clinical Research Associate (a 7-days course) Professional management: Ms. Yehudith Wexler
	This course provides the basic knowledge in clinical trial management and qualifies the students to become a Clinical Research Associates - CRA. The course opens a new, dynamic and challenging channel for a fascinating and full satisfaction work, with specific promotion possibilities in a scientific – medical professional environment
10/10/2010 3 - Day Course	GCP - Good Clinical Practice Professional management: Ms. Yehudith Wexler
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
22/11/2010 2 - Day Course	MedDRA® : A Comprehensive Training Course Lecturer: Dr Elliot Brown
07/12/2010 Day Course	Good Clinical Practice 2010 - Clinical Trials for Medical Device Lecturer: Dr. Monica Tocchi
08/12/2010 2 - Day Course	Clinical Project Management Lecturer: Dr Stanley Garbus
	The course begins by describing the basic fundamentals and pharmaceutical industry standards of project management techniques. Details are presented for understanding clinical trial costs and developing timely budgets to create successful study completion on budget. Participants learn skills of leadership, negotiation and communication that will positively impact the success of clinical projects.
21/12/2010 2 - Day Course	A deep Insight into Pharmacovigilance and Risk Management Regulatory Systems, advanced level Lecturer: Dr. Irene Fermont
21/12/2010 Day Course	CDISC Workshop Lecturer: Mr. Eyal Wultz
27/12/2010 2 - Day Course	Optimizing the Drug Development Process using PK/PD Modeling Lecturer: Dr. Serge Guzy, USA

Past Activities

2010

08/07/2010 Day Course	Data Management & Statistical Methods in Clinical Trials Lecturer: Ms. Tali Azulay, Mr Gil Harari
	The presentation and interpretation of clinical efficacy and safety results from clinical trials is a core component of regulatory submissions for the approval of medical products and devices. These results, in turn, derive from clinic data which is collected through a regulated process involving clinical trial Sponsors, investigative sites, and contract research organizations.
08/07/2010 7 - Day Course	Qualification of CRA - Clinical Research Associate (a 7-days course) Professional management: Ms. Yehudith Wexler
	This course provides the basic knowledge in clinical trial management and qualifies the students to become a Clinical Research Associates - CRA. The course opens a new, dynamic and challenging channel for a fascinating and full satisfaction work, with specific promotion possibilities in a scientific – medical professional environment
08/07/2010 3 - Day Course	GCP - Good Clinical Practice Professional management: Ms. Yehudith Wexler
16/06/2010 2 - Day Course	Development of Combination Products - Regulatory & Clinical Considerations Lecturer: Dr. Barbara Fant
15/06/2010 Day Course	When Safety Meets Regulation Lecturers: Dr. Barbara Fant, Dr Irene Fermont
TBA Day Course	Clinical Leadership and Governance for Trial Sponsors Lecturer: Dr. Monica Tocchi
28/04/2010 Day Course	Phase Appropriate GMP for Investigational Products Lecturer: Ms. Karen Ginsbury
25/04/2010 7 - Day Course	Qualification of CRA - Clinical Research Associate (a 7-days course) Professional management: Ms. Yehudith Wexler
	This course provides the basic knowledge in clinical trial management and qualifies the students to become a Clinical Research Associates - CRA. The course opens a new, dynamic and challenging channel for a fascinating and full satisfaction work, with specific promotion possibilities in a scientific – medical professional environment
25/04/2010 3 - Day Course	GCP - Good Clinical Practice Professional management: Ms. Yehudith Wexler
22/03/2010 2 - Day Course	Medical Device Clinical Studies & Clinical Evaluation for CE Marking in 2010 Lecturer: Dr. Monica Tocchi
	This course is intended for manufacturers who are planning to bring their devices to the European market and need clinical data to support their product claims according with the new EU Directives, which take effect on March 21, 2010. One key change is the requirement of more clinical data for devices placed on the market in any of the 27 EU member nations. For clinical investigations, there will be more scrutiny of clinical dossiers and communication between authorities, for example, refusal from one country will be shared with all other nations. Devicemakers need practical tools for immediate compliance with the new requirements, that this course will provide.
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.
15/02/2010 2 - Day Course	Pharmacovigilance - basic level Lecturer: Dr. Irene Fermont
10/02/2010 6 - Day Course	Qualification of Clinical Research Coordinators (CRC) Professional management: Ms. Yehudith Wexler
TBA Day Course	How to disable your next regulatory clinical site inspection Lecturer: Mr. Steve Schwartz
	This course will benefit the investigators and site staff who will be inspected, the sponsor CRA, and institution quality staff and clinical administrators.
02/02/2010 3 - Day Course	Developing Clinical Quality Assurance Audit Skills and Procedures (CQA) Lecturer: Mr. Steve Schwartz, USA
04/01/2010 15 Meetings	Qualification of CRA - Clinical Research Associate (regular course) Professional management: Ms. Yehudith Wexler
04/01/2010 Meeting	GCP - Good Clinical Practice Professional management: Ms. Yehudith Wexler

2009

15/07/2009 Day Course	How Current Are You? Review of New Industry and Regulatory Expectations For Biopharmaceutical Products Lecturer: Dr. Ana Menendez, USA
	2008 was a banner year for generating important industry white papers and regulatory guidelines for biopharmaceutical products. This meeting specifically addresses updates that should be implemented in post-2009 development and validation programs both in the GMP and the GLP arena.
05/07/2009 2 - Day Course	Preparing Protocols & Final Reports for Clinical Trial Lecturer: Dr. Shayne Gad
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.
TBA 2 - Day Course	Medical Device Clinical Studies & Clinical Evaluation for CE Marking Lecturer: Dr. Monica Tocchi
18/05/2009 2 - Day Course	Patient Recruitment Strategy: A Comprehensive Workshop for Investigative Sites and Sponsors Lecturer: Mr. John Needham (USA)
	The course focuses on the skills of the people who are responsible for recruitment success including their personal development (Me), their relationship with their immediate supervisor or client (We) and the role of their efforts in the overall study and the public’s health (Us).
04/05/2009 2 - Day Course	Capsule Technology & Encapsulation of Commercial & Clinical Supplies Lecturer: Mr. Donald K. Lightfoot, USA
	A comprehensive capsule technology presentation covering the manufacturing of empty and filled two piece capsules, fundamentals of encapsulation, blinding of clinical supplies utilizing over-encapsulation and an extensive review of the encapsulation machinery and equipment.
22/03/2009 3 - Day Course	GCP - Good Clinical Practice Professional management: Ms. Yehudith Wexler
TBA Day Course	GMP / GCP / GLP – The overlap in preparation of material for Preclinical and Clinical Trials Lecturer: Ms. Karen Ginsbury

2008

23/12/2008 Day Course	An Introduction to Clinical Data Management Lecturer: Ms. Tali Azulay
	The presentation and interpretation of clinical efficacy and safety results from clinical trials is a core component of regulatory submissions for the approval of medical products and devices. These results, in turn, derive from clinic data which is collected through a regulated process involving clinical trial Sponsors, investigative sites, and contract research organizations.
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.
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.
11/09/2008 Day Course	An Introduction to CDISC (Clinical Data Interchange Standards Consortium) Lecturer: Wayne Kubick
07/09/2008 2 - Day Course	Pharmaceutical Product Risk Lecturer: Dr Stanley Garbus (USA)
	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.
03/09/2008 2 - Day Course	Clinical Project Management Lecturer: Dr Stanley Garbus - USA
	The course begins by describing the basic fundamentals and pharmaceutical industry standards of project management techniques. Details are presented for understanding clinical trial costs and developing timely budgets to create successful study completion on budget. Participants learn skills of leadership, negotiation and communication that will positively impact the success of clinical projects.
07/07/2008 Day Course	An Introduction to Protocol and CRF development Lecturers: Ms. Tali Azulay, Dr. Kobi Atsmon
28/05/2008 2 - Day Course	Global Orientation in Conducting Clinical Trials Symposia Professional management: Ms. Tali Azulay
12/05/2008 3 - Day Course	Developing Clinical Quality Assurance Audit Skills and Procedures (CQA) Lecturer: Mr. Steve Schwartz
	Roles and Responsibilities for Auditors and Managers
25/03/2008 Day Course	Conducting clinical trials: strategies for compliance with regulatory requirements Professional management: Ms. Tali Azulay
	This seminar focuses on the latest updates in the practical tools for us to learn from past clinical experience and understand the regulatory guidelines. Participants will profit extensively from this seminar, whether they design clinical trials or build strategies to comply with regulatory guidelines for data submissions.
19/02/2008 2 - Day Course	Medical Device Clinical Studies in Europe & Clinical Evaluation for CE Marking Lecturer: Dr. Monica Tocchi, Italy
TBA 2 - Day Course	Regulatory and Clinical Considerations in the Development of Combination Products Lecturer: Dr. Barbara S. Fant, Pharm.D., USA
	Development and FDA approval of a combination product is inherently more complex than individual entity products. This course will provide an overview of the regulatory pathway and the development lifecycle for combination products. Characteristics that are common and those that are unique to medical device, drug, and biologic development will be presented. Considerations in clinical trial design, project management, and clinical monitoring of combination product clinical trials will be presented.

2007

14/11/2007 Day Course	Introducing eProducts for clinical trials: EDC and ePRO solutions Professional management: Phase Forward, PHT
13/11/2007 Day Course	An Introduction to Clinical Data Management Lecturer: Tali Azulay & Guest Lecturer: Dr. Paul A. Bleicher (USA)
14/05/2007 Day Course	Quality Clinical Data Mini-workshop Professional management: Ms. Tali Azulay

2006

09/09/2006 2 - Day Course	GMP in Production of Phase I Clinical Trial Materials Lecturer: Karen Ginsbury