If you are active in Pharma Regulatory Affairs, this is a must conference that provides a brand NEW platform that will allow you to access, participate and engage with senior GCC government regulators and industry professionals with a great lineup of international industry experts transferring valuable knowledge
This training workshop is intended for Qualified persons for pharmacovigilance and national PV officers who would like to improve their daily practice and better understand regulatory expectations and practical implications. The workshop is led by an expert instructor who has been a EU/EEA QPPV for 17 years and helped establish the EU QPPV Forum with which he is still involved. Together with two experts from MOHAP UAE and CAPA (Ministry of Health and Population Egypt), they aim to interactively help you better understand the daily challenges you face and hear about solutions from others in similar situations.
This hands-on training given by EXTEDOs Regulatory Experts will be based around eCTD, the format itself and the relevant surrounded common business processes.
This time the training will consist from 2 parts:
27th of September – Level 1. You will gain basic understanding of what eCTD is about and the practical experience on how to build and compile a valid submission.
28th of September – Level 2 is an advanced level where we will analyse the eCTD format in detail, check the validation rules, create our own test submissions, including errors and how to validate them.
Good and knowledgeable sessions. Good regulatory attendance to showcase their workHrishikesh Dhongade, Novartis
It covers the main topics needed in regulatory with the high professional speakers. It was impressive conferenceNoura Al Hafez, Pharmazone Medical Equipments
It was good& Informative too. All speakers were very good and experiencedReema Dsouza, Starlink Drug Store
Summit was interactive. Being in an industry outside from GCC, now we got awareness what is the actual position of pharma marketSyed Khalid, PharEvo