Agenda

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Agenda2019-02-28T16:19:38+03:00

e-Submission forum 2019

Under the patronage of Dr. Mohammed Al-Rubaie, the general director of Directorate General of Pharmaceutical Affairs & Drug Control (DGPA&DC), ministry of health, the Sultanate of Oman.

Forum theme: authority, applicants & tools

Venue: hotel venue to be announced, Muscat, Sultanate of Oman

Date: Sunday 3rd March – Monday 4th March 2019

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Sunday 3rd March 2019

Registration 08:00 09:00
Opening 09:00 09:30 Dr. Mohammed Al-Rubaie
Dr. Mohammed Saleem
Austria, AGES, experience of eCTD, e-workflow& next projects. 09:30 10:30 Dr. Christa Wirthumer-Hoche
Break 10:30 11:00  
Oman MOH eCTD experience overview 11:00 11:30 Dr. Tariq Essam Nasser
Saudi SFDA eCTD experience overview 11:30 12:00 Dr. Hassaan S. Alwohaibi
Saudi SFDA SDR system experience overview 12:00 12:30 Dr. Hassaan S. Alwohaibi
GCC central authority eCTD experience overview 12:30 13:00 Dr. Sara K. Almuteb
Lunch 13:00
 14:00
Kuwait registration system 14:00
14:30
Dr. Sarah Al-Maqseed
NHRA eCTD experience overview 14:30 15:00 Dr. Nabeela Ahmed Memon
Break 15:00 15:30
Day end authority only round table recommendations 15:30 16:30
Day ends 16:30

Monday 4th March 2019

  Time Target speakers
Jordan FDA eCTD experience overview 09:00 09:30        Dr. Eman Ali Al-Awamleh
Applicant experience – Julphar 09:30 10:15        Dr. Mamoona Firdous
Applicant submission compatibility issues 10:15 11:00        Dr. Karl-Heinz Loebel
Coffee break 11:00 11:30
Best practices for eCTD compilation, submission & review 11:30 12:15        Dr. Karl-Heinz Loebel
Applicant experience
12:15 13:00        Dr. Mohammed Saleem
Lunch 13:00 14:00
Validation issues & best practices 14:00 14:45        Dr. Karl-Heinz Loebel
eCTD vendor experience in MEA 14:45 15:30 Mr. Michael Gessert
Coffee break 15:30 16:00
Day end Joint round table recommendations 16:00 17:00
Forum ends & certificates collection 17:00