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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
                            DAY TWO
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