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DAY THREE - CET (Central European Time, GMT+1)
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DAY THREE - CET (Central European Time, GMT+1)
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09:35 - 10:0025 mins
Regulatory Information Management Focus Day
How Can RIM be used for Effective Reporting?
- Akash Palia - Senior Associate Regulatory Information Management, Alexion
09:35 - 10:0025 mins
Global eSubmissions
Networking time
09:35 - 10:0025 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Networking time
10:05 - 10:3025 mins
Regulatory Information Management Focus Day
Best practices to having an end to end RIM system
- Matthias Glatz - IT-Manager Regulatory Affairs, Novartis Pharma AG
10:05 - 10:3025 mins
Global eSubmissions
Feedback on eCTD Submissions with China
- Alice Zhou - DRA Operations, Novartis
10:05 - 10:3025 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Understanding MENA’s Regulatory Landscape
- Ilona Putz - Consultant, Independent Consultant
10:35 - 11:0025 mins
Regulatory Information Management Focus Day
Case Study : Strategies to Enable Our Regulatory Department to Accelerate Submissions of Medicines Globally
- Vijay Reddi - Regulatory Approvals and Information Lifecycle (RAIL) lead, Roche
10:35 - 11:0025 mins
Global eSubmissions
Update on Japan eCTD
- Takeshi Adachi - President, PPG Inc, Japan
10:35 - 11:0025 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Interactive: Shared Experiences for Product Registration for the Gulf Cooperation Council (GCC)
- Abdul Mateen - Associate Regulatory Project Director, AstraZeneca, UK
- Khaled Rozza - Regulatory Affairs Manager, GCC, Acino
11:05 - 11:3025 mins
Regulatory Information Management Focus Day
Robust RIM systems with IQVIA
11:05 - 11:3025 mins
Global eSubmissions
Industry feedback on XML Submissions in EAEU Region
- Spotlight Session - -, -
11:05 - 11:3025 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Pharmacovigilance and risk management activities in MENA
- Manal Younus - Head of Iraqi Pharmacovigilance Centre, Ministery of Health
11:30 - 12:0535 mins
Networking Break including Roundtables with Veeva
12:05 - 12:3025 mins
Regulatory Information Management Focus Day
Spotlight session
12:05 - 12:3025 mins
Global eSubmissions
Feedback from Saudi Arabia on eCTD
- Nadeen Al Dibsi - Senior Manager Regulatory Affairs - SFDA,GCC & JFDA, AlSafa
12:05 - 12:3025 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Dual Dialogue: Evaluating the Biosimilars Landscape in Turkey and MENA
12:35 - 13:0025 mins
Regulatory Information Management Focus Day
Case Study: Data Cleaning and Data Maintenance
12:35 - 13:0025 mins
Global eSubmissions
Dual Dialogue: Feedback on eCTD Submissions in Jordan
12:35 - 13:0025 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Regulatory Updates for Turkey: Prioritisation and Localisation - High Impacts for Foreign Investors
- Figen Kabadas Oge - Head of Regulatory Affair, Delpharm
13:05 - 13:3025 mins
Regulatory Information Management Focus Day
Data Governance
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
13:05 - 13:3025 mins
Global eSubmissions
Panel: Harmonisation of Submissions in the EFIRA Region
- Nadeen Al Dibsi - Senior Manager Regulatory Affairs - SFDA,GCC & JFDA, AlSafa
13:05 - 13:3025 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Dual Dialogue: Shared Experiences on Launching Products in Russia/ EAEU and CIS Countries
- Edelgard Rehak - Consultant, Edelgard Rehak Consulting
13:30 - 14:3060 mins
Networking Break
14:30 - 14:5525 mins
Regulatory Information Management Focus Day
The Future of RIM with CLOUD
- Rodrigo Palacios - Regulatory Technology Policy Lead, Roche
14:30 - 14:5525 mins
Global eSubmissions
eCTD in Brazil
- Patrícia Kott Tomazett - Health Regulation Specialist, General Management of Drugs - GGMED, Brazilian Health Surveillance Agency (ANVISA), Brazil
14:30 - 14:5525 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
The Eurasian Economic Union (EAEU): Evaluating the Regulatory Landscape
- Alex Dranov - Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe, GmbH & Co. KG, Germany
15:00 - 15:2525 mins
Regulatory Information Management Focus Day
Using Innovative Technologies to Generate IDMP Dataset for Qualification – Usage of Machine Learning & Robotic
- Argha Nag - Global Regulatory Systems & Data Governance Lead, AstraZeneca
15:00 - 15:2525 mins
Global eSubmissions
Global eCTD Updates
- Olga Alfieri - Director, Global Submission Management, GRO, Eisai, USA
15:00 - 15:2525 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Product Labelling Under the EAEU and CIS Markets
- Rebecca Jackson - Team Leader, Worldwide Safety & Regulatory, Pfizer
15:25 - 15:4015 mins
Regulatory Information Management Focus Day
Closing Remarks
15:25 - 15:4015 mins
Global eSubmissions
Closing Remarks
15:25 - 15:4015 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Closing Remarks
15:40 - 15:455 mins
End of Conference
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