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Workshops

Pharmacovigilance Training

Start Date:

TBC

End Date:

TBC

Event Brief:

This meeting is intended for senior pharmacovigilance professionals who would like to improve their daily practice and better understand regulatory expectations and practical implications. The meeting will be chaired by a GCC PV expert in contract research, authority, consultancy and the industry, they aim to interactively help you better understand the daily challenges you face and hear about solutions from others in similar situations.

Level:

Professionals

Venue:

Virtual

eCTD Training

Start Date:

TBC

Duration:

1 day

Event Brief:

This training is organized to bring the two players “Industry” and “Authority” together. Participants will work collaboratively on submissions along a typical eCTD scenario.

The training starts with the agency view: A GCC eCTD dossier with the first two sequences (0000, 0001), which has been submitted to the authority, will be checked using the same reviewing tools as the authority has in use. Filters and different views will be used, you will see the document life cycle and how hyperlinks are used in the reviewing process. Deficiencies in the dossier will be noticed and a Deficiency Letter will be sent to the pharmaceutical company, who initially submitted the dossier.

On the industry side, the Deficiency Letter is received and a new sequence is created in response. Missing documents are added or appended, wrong documents are replaced. Hyperlinks are created, an incremental export is performed. Finally, the follow-up submission is finished, exported and validated. An additional validation with EURSvalidator is done before the new sequence is sent to the authority.

During the day you will change perspectives, learn and discuss the needs of your counterparts and achieve a common understanding of the eCTD process. Furthermore, we will offer you the opportunity to use all the tools of the EXTEDO suite.

Level:

Professionals

Venue:

Habtoor Grand Resort, Dubai, UAE

Middle East Medical Tender Training

Start Date:

TBC

Duration:

2 days

Event Brief:

The 2019 edition of the Tender Training was a huge success. Due to the popular demand we have ben compelled to launch our 2nd edition. This edition will be online contrary to the 1st edition due to the Coronavirus outbreak.

With the increasing population in Middle East, the demand for medical supplies is also bound to increase. It is projected that these countries would spend about $71 billion in healthcare by 2020. Looking at this it is pertinent that the people involved in the tender business are aware of the tender mechanisms in this region.

Against this backdrop, we are organizing the tender training once again that will focus on the directories of the tender business such as quality, fair prices, timelines, delivery, after sales services etc. Highly eminent speakers from the industry will share their experience, knowledge and thoughts on the same.

This two-day training will help delegates expand their understanding of the market and extensive knowledge of the industry.

Level:

Professionals

Venue:

Virtual