1st & 2nd SEPTEMBER, 2021
eCTD TRAINING
We want to bring the two groups of players “Industry” and “Authority” together. You work together on submissions along a typical eCTD scenario. During the day you will 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:
Day 1, eCTD Training 2021
1st September 2021
08:00 - 09:00
09:00 - 09:10
Welcome Address Dr Mona Al Moussli Managing Director, PRA Group
09:10 - 09:30
Inauguration and Keynote Presentation H. E. Dr Amin Hussain Al Amiri UAE Assistant Undersecretary of Public Health Policy and Licensing Sector, Ministry of Health and Prevention
09:30 - 12:30
Session 1 - Regulatory Updates in the Pharma Market through GCC Moderated by: To be specified
09:30 - 09:50
UAE Regulations MOHAP
09:50 - 10:10
Oman Regulations Ph. Nisreen Mohammad Nassr
10:10 - 10:30
Bahrain Regulations Dr Mariam Al Jalahma
10:30 - 11:00
Q&A Panel 1
11:00 - 11:30
Coffee & Networking Break
11:30-11:50
GCC Summit TBC
11:50-12:10
KSA Regulations Medical Devices: Bader Aloufi
12:10-12:30
Kuwait Regulations
12:30 - 13:00
Q&A
13:00 - 14:00
Lunch and Networking Break
13:15-14:15
Session 2: Track and Trace and Serialization Evotech and GS1
14:15-15:00
Session 3 - Regulations Pharma advertising
15:00- 15:30
Session 4: Market Access and Pricing/ Value based pricing
15:30 - 16:00
Coffee Break
16:00 - 16:45
Round Table Breakouts - UAE and Gulf Council
Day ENDS
Day 1, eCTD Training 2021
Our Speakers
Michael Faust
Business Consultant RCC, EXTEDO, Germany
Michael studied and graduated in Biology, focusing on neurobiology and working in the neuroanatomical research field.
In 2017 he joined EXTEDO as a Junior Business Consultant, where he work in the Regulatory Competence Center since then. He provides software trainings and business consulting internationally, internal and external support as well as tracking regulatory updates on registration procedures globally.
Asmaa Khalil
MENA RA Manager, Boston Biopharma Ltd, Malta
Asmaa Khalil is manager of MENA RA at Boston Biopharma Limited. She has more than 15 years’ experience in global regulatory affairs “Africa, CIS, America, EU & APAC”.
Asmaa is expert consultant in CTD, NeeS & eCTD compilation and submission of dossiers. She was the speaker of more than 30 worldwide workshops relevant to pharmaceutical industry and CTD\eCTD sessions.
Asmaa earned her B.S. in Pharmaceutical Sciences from Cairo University, and her M.Sc. in Biochemistry.
Day 2, eCTD Training 2021
2nd September 2021
08:30 - 9:00
Breakfast Registration and Meet Up Online Login and Networking Room
09:00 - 09:15
Morning welcome and Honorary mention
09:15 - 09:30
Patents: Pharma Gulf Region: Ministry of Economy
09:30 - 10:30
Session 1 - Regulatory Updates in the Pharma Market through GCC Moderated by: To be specified
09:30 - 09:50
Algeria / Sudan Regulation
09:50 - 10:10
Iraq Regulations
10:10 - 10:20
Lebanon Regulations
10:20 - 10:50
Q&A Panel Session
10:50 - 11:15
Coffee And Networking break
11:15 - 11:45
Session 2: Biologic
11:45 - 12:15
Session 3: Orphan Drugs
12:15 - 12:45
Session 4: Logistics and the Freezone aspect within Pharma Companies
12:45 - 13:15
Session 5: Panel discussion - Biosimilars and the access in the GCC Market
13:15 - 14:15
Lunch and Networking Break
14:15 - 14:30
Covid 19 and the World Wide pandemic and where we are now
14:30 - 15:00
Session 6: Expert in Clinical Trials and updated policies
15:00 - 15:30
Coffee Break
15:30 - 16:15
KSA Roundtable Oman Round Table
16:00 - 16:45
Round Table Breakouts - UAE and Gulf Council
16:15 - 17:00
Roundtable break outs - Iraq Kuwait Round table
Day ENDS
Day 2, eCTD Training 2021
Our Speakers
Michael Faust
Business Consultant RCC, EXTEDO, Germany
Michael studied and graduated in Biology, focusing on neurobiology and working in the neuroanatomical research field.
In 2017 he joined EXTEDO as a Junior Business Consultant, where he work in the Regulatory Competence Center since then. He provides software trainings and business consulting internationally, internal and external support as well as tracking regulatory updates on registration procedures globally.
Asmaa Khalil
MENA RA Manager, Boston Biopharma Ltd, Malta
Asmaa Khalil is manager of MENA RA at Boston Biopharma Limited. She has more than 15 years’ experience in global regulatory affairs “Africa, CIS, America, EU & APAC”.
Asmaa is expert consultant in CTD, NeeS & eCTD compilation and submission of dossiers. She was the speaker of more than 30 worldwide workshops relevant to pharmaceutical industry and CTD\eCTD sessions.
Asmaa earned her B.S. in Pharmaceutical Sciences from Cairo University, and her M.Sc. in Biochemistry.
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