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20th - 22nd April 2021
★ 100% virtual conference ★Presented in Central European Time (CET)
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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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10:05 - 10:3025 mins
Regulatory Information Management Focus Day
How Can RIM be used for Effective Reporting?
  • Akash Palia - Manager, Regulatory Information Management, Alexion
10:05 - 10:3025 mins
Global eSubmissions
Feedback on eCTD Submissions with China
  • Cecilia Sirichoke - Associate Director, Regulatory Systems & Strategy, Novartis Pharmaceuticals Corp.
10:05 - 10:3025 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Understanding MENA’s Regulatory Landscape
  • Ilona Putz - Independent Consultant, PULONA Emerging Markets FZE
10:35 - 11:0025 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
10:35 - 11:0025 mins
Global eSubmissions
Update on Japan eCTD
  • Takeshi Adachi - President, PPG Inc, Japan
10:35 - 11:1540 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
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
Digitization of Regulatory Affairs: The intelligent regulatory data science platform
  • Cecile Riboud - Senior Director Europe Integrated Global Compliance, IQVIA
  • Jens-Olaf Vanggaard - Director, Global Regulatory and Safety Solutions, IQVIA
11:05 - 11:3025 mins
Global eSubmissions
APAC eCTD Roundtable
  • Ziqun Han - Director, Zen Medical Science Consultancy,
11:20 - 11:4525 mins
Regulatory Affairs in Russia, CIS, MENA & Turkey
Pharmacovigilance and Risk Management Activities in MENA
  • Manal Younus - Head of Iraqi Pharmacovigilance Centre, Iraqi Ministry of Health
11:45 - 12:2035 mins
Networking Break including Roundtables with Veeva
    12:20 - 12:4525 mins
    Regulatory Information Management Focus Day
    Utilize IDMP and Data Governance to improve your business process.
    • Niels Buch Leander - Global Head of Regulatory Affairs, NNIT, Denmark
    12:20 - 12:4525 mins
    Global eSubmissions
    Feedback from Saudi Arabia on eCTD
    • Nadeen Al Dibsi - Senior Manager Regulatory Affairs - SFDA,GCC & JFDA, AlSafa
    12:20 - 12:4525 mins
    Regulatory Affairs in Russia, CIS, MENA & Turkey
    Biosimilars in the MENA Region and Turkey
    • Dr Khalid Al-Kinani - Head of the Biologics and Biosimilars Registration Committee, Iraqi Ministry of Health
    12:50 - 13:1525 mins
    Regulatory Information Management Focus Day
    Case Study : Strategies to Enable Our Regulatory Department to Accelerate Submissions of Medicines Globally
    • Vijay Reddi - Regulatory Transformation Lead, Roche
    12:50 - 13:1525 mins
    Global eSubmissions
    Case Study : Strategies to Enable Our Regulatory Department to Accelerate Submissions of Medicines Globally
    • Vijay Reddi - Regulatory Transformation Lead, Roche
    12:50 - 13:1525 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 Affairs, Delpharm
    13:20 - 13:4525 mins
    Regulatory Information Management Focus Day
    Data Governance
    • Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
    13:20 - 13:4525 mins
    Global eSubmissions
    EFPIA recommendations for eCTD
    • Tim Powell - Associate Director, Submission Sciences, Biogen
    13:20 - 13:4525 mins
    Regulatory Affairs in Russia, CIS, MENA & Turkey
    Guidance on Launching Products in Russia/ EAEU and CIS Countries
    • Edelgard Rehak - Consultant, Edelgard Rehak Consulting
    13:45 - 14:4560 mins
    Networking Break
      14:45 - 15:1025 mins
      Regulatory Information Management Focus Day
      Cloud submissions: Accumulus Synergy
      • Rodrigo Palacios - Associate Director, Global Regulatory Policy, Roche
      • Louise Gill - VP, Regulatory Policy, Global Regulatory Affairs, GSK
      14:45 - 15:1025 mins
      Global eSubmissions
      eCTD in Brazil
      • Patrícia Kott Tomazett - Health Regulation Specialist, General Management of Drugs - GGMED, Brazilian Health Surveillance Agency (ANVISA), Brazil
      14:45 - 15:1025 mins
      Regulatory Affairs in Russia, CIS, MENA & Turkey
      Legislation updates: main points you should know to successfully access EAEU and CIS markets
      • Nargiz Asgarova, BSc, MBA - Regulatory Affairs Projects Manager CIS, Biomapas
      15:15 - 15:4025 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
      15:15 - 15:4025 mins
      Global eSubmissions
      Global eCTD Updates
      • Olga Alfieri - Director, Global Submission Management, GRO, Eisai, USA
      15:15 - 15:4025 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
      15:40 - 15:5515 mins
      Regulatory Information Management Focus Day
      Closing Remarks
        15:40 - 15:5515 mins
        Global eSubmissions
        Closing Remarks
          15:45 - 16:1025 mins
          Regulatory Affairs in Russia, CIS, MENA & Turkey
          Product Labelling Under the EAEU and CIS Markets
          • Rebecca Jackson - Team Leader, Worldwide Safety & Regulatory, Pfizer
          16:10 - 16:2515 mins
          Regulatory Affairs in Russia, CIS, MENA & Turkey
          Closing Remarks
            16:25 - 16:305 mins
            End of Conference
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