|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBA
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. |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14/10/2012
7 - Day Course
|
CRA – Monitoring and Coordinating Clinical Trials (a 7-day 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 |
|
|
|
|
|
|
|
01/07/2012
7 - Day Course
|
CRA – Monitoring and Coordinating Clinical Trials (a 7-day 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 |
|
|
|
|
|
10/06/2012
7 - Day Course
|
CRA – Monitoring and Coordinating Clinical Trials (a 7-day 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 |
|
|
|
|
|
|
|
|
|
21/03/2012
7 - Day Course
|
CRA – Monitoring and Coordinating Clinical Trials (a 7-day 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 |
|
|
|
28/02/2012
1 - Day Course
|
Pharmacokinetic (PK) and Pharmacodynamic (PD) Considerations
Lecturer: Prof. Roni Levy, Scientific Director, Pharmaseed Ltd
|
| |
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. |
|
29/01/2012
15 Meetings
|
CRA – Monitoring and Coordinating Clinical Trials
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 |
|
|
|
|
|
|
|
|
|
TBA
1 - Day Course
|
Documenting Clinical Studies
Lecturer: Dr. Monica Tocchi, Italy
|
| |
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
1 - 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. |
|
|
|
04/12/2011
7 - Day Course
|
CRA – Monitoring and Coordinating Clinical Trials (a 7-day 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 |
|
|
|
|
|
|
|
11/09/2011
7 - Day Course
|
CRA – Monitoring and Coordinating Clinical Trials (a 7-day 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 |
|
|
|
12/06/2011
7 - Day Course
|
CRA – Monitoring and Coordinating Clinical Trials (a 7-day 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 |
|
|
|
|
|
27/03/2011
7 - Day Course
|
CRA – Monitoring and Coordinating Clinical Trials (a 7-day 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 |
|
|
|
|
|
23/01/2011
15 Meetings
|
CRA – Monitoring and Coordinating Clinical Trials
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 |
|
|
|
11/01/2011
1 - Day Course
|
Pharmacokinetics and Pharmacodynamics - Basic Principles
Lecturer: Prof. Roni Levy, Scientific Director, Pharmaseed Ltd
|
| |
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.
|
|
|
|
|
|
TBA
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. |
|
|
|
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 |
|
|
|
08/07/2010
1 - 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 |
|
|
|
|
|
|
|
|
|
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 |
|
|
|
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
1 - 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. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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. |
|
|
|
|
|
|
|
23/12/2008
1 - 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
1 - 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. |
|
|
|
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. |
|
|
|
|
|
|
|
25/03/2008
1 - 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. |
|
|
|
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.
|
|