We can hold 1-day training under the supervision of first persons of Regulatory Affairs and experts from EU , other first persons of RA will be invited as speakers in Conference mode.
The price of such training will be about 385 Euro for 1 participant, duration – from 9:00 to 17:00 CET with 3 short 15 minutes coffee-brakes and 1 hour lunch. It can be done for audience up to 100 persons.
Training Description: This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure. There will also be a discussion on the new medicines legislation, and how it changes access to centralized procedure and alters regulatory data protection, core document review including IMPD and IB Ph I trials, non-interventional trials, orphan drugs, studies required pediatric and geriatric studies, vaccines, medical device studies, definition of IMP, regulatory assessment of study.
This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the agencies.
Second option -it is also possible to arrange training for staff at any time, but then it would be not a real-time communication with Trainer.
For second option members receive educational materials, use video presentations. Then, if something is not clear they can get response from Trainers within 1 working day.
If this proposition is suitable for you, we can provide detailed program.
See SYSTEM REQUIREMENTS in attachment 1.
for attending Live Sessions
Operating System (Windows XP Home, XP Pro,Windows 2000,Windows 2003,Windows Vista (all editions)
Web Browser (Internet Explorer,Mozilla Firefox,Opera, Netscape, Google Chrome)
(Java from Sun Microsystems must be installed)
Hardware Requirements (CPU: 266 MHz Pentium II or Higher,Recommended: 1 GHz Pentium III or higher ) RAM: min 256 MB (Recommended: 512 MB or above
Data Storage (HDD: min 20 MB disk free space, rquired disk space may increase within the
session. Keep up 100 MB disk free space.)
Other software requirements
Usually e-NBScience does not require other programs be installed on your system. Sometimes, however, you may need to install a specific audio/video codec if experiencing audio problems or unable to participate in a videoconference. In this case the system will inform you about the problem.
Participants are required to have a microphone installed.
In case of a videoconference you must have a video camera installed and configured. Please
refer to the specific device documentation.
For best whiteboard performance we recommend using a digital tablet or other pointing device. It will enable you to do free handwriting. e-NBScience supports almost all of the digital tablets selling today.
PowerPoint presentations do not require PowerPoint be installed on participants’ computers.
Presenters need PowerPoint as long as the slide show is uploaded.
Network and Bandwidth Requirements
The participant computer must be connected to the Internet.
Min connection type is a dial-up connection with at least 56 kbps bandwidth. Recommended connection type is ADSL or LAN.
e-NBScience usually has no problems with firewalls while connecting to an online session.
If you are located behind a proxy you may need to ask you system administrator to allow access to specific host/port if you are experiencing connection problems.
We recommend slow connection users to avoid multitasking while in a live session.
If you are running on a slow Internet connection, please avoid activities
consuming bandwidth when in a live session.