 |
|
|
|
|
|
|
Clinical Trials |
|
|
|
Upcoming
2011
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
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
2006
|
| |
|
 |
All Rights Reserved 2006. Bioforum.org.il
P.O.B. 4034 Ness Ziona, Israel, 70400, Phone: +972-8-931-3070, Fax: +972-8-931-3071
|
Created by WebStudio.co.il
|
|
|
 |