08.00 Registration
09.00 Opening remarks from the Chairperson
09.10 China’s Regulatory Reform and Impact on the Pharmaceutical Industry
09.45 Practical Guidance for Drug Registration Compliance in China
10.20 Understanding the regulatory environment and practical considerations for market entry in South Korea
09.10 PANEL BREXIT: Analysing Outcomes and Devising a PoA
09.45 Feedback on EMA’s IDMP Implementation Guidelines
10.20 Improving Data Integration Across the Business
09.45 Case Study - Implementing eCTD within National Procedures
10.20 Regulatory Agency Perspective: Feedback, Plans and Practical Advice for eCTD Submissions
10.55 Morning Coffee
11.20 Updates on Regulatory Harmonization Efforts for Pharmaceutical Products in ASEAN
11.55 Fast-Tracking Approvals & GMP Guidelines Updates in Taiwan
11. 20 Lessons Learned from Large Scale Data Migration
11.55 Utilizing AI and Data Analytics to Optimise your Regulatory Strategy
11.20 An Update on Clinical Trial Applications in the EU
11.55 Best Practice for Implementing the EU Falsified Medicines Directive
12.30 Lunch
14.00 Biologics Registration & Approvals in Malaysia
14.35 Marketing authorizations and latest regulatory updates in India
15.10 Best strategies for successful product registration in India
14.00 Case Study - Strategies for Ensuring High Quality Data
14.35 Industry Case Study: Cross Functional Collaboration - Data Integration Across the Business
15.10 Industry Feedback on the Falsified Medicines Directive: Post Implementation
14.00 Experiences of Submitting Dossiers in China
14.35 Assessing the Latest Developments Towards eCTD in Singapore
15.10 Case Study: Implementing a Successful eSubmissions Strategy at a SME
15.45 Afternoon Coffee
16.15 Understanding Product Requirements and Expectations in Japan
16.50 Updates from Australia: Current Regulatory Landscape and Opportunities for the Pharmaceutical Industry
17.20 APAC Panel Session: Regulatory Feedback and Industry Experiences
16.15 Maintaining Data Quality to Ensure an Effectively Operating RIM System
16.50 Designing an End-to-End RIM System
17.20 PANEL: The Future of Information Management - Shifting the Mindset from Tactics to Strategy
16.15 Guidance from South East Asia on the Harmonisation and Implementation of CTD
16.50 Outlining Current Regulatory Submission Status in Jordan
17.50 Updates on Submissions in Australia
17.50 End of Day 1 and Networking Drinks
09.10 Navigating the Russian Regulatory Landscape
09.45 Case study: Best Practice for Normative Document Preparation
10.20 Sharing Experiences of Russian GMP Inspections: Success & Failure
09.10 SPOR Regulatory Landscape and Implementation Feedback
09.45 Best Practice for Successful Implementation of OMS & RMS
10.20 A Systematic Approach to PMS Preparations
11.25 Exploring the Serialisation and Labelling Requirements in Russia
12.00 Reviewing the Regulatory Environment in Ukraine
11.25 The IDMP Substance Management System
12.00 CESSP Essentials: What to Expect from Phase 1
14.00 Latest Status Update of the Eurasian Economic Union (EEU) and Implications for Industry
14.35 Reviewing the regulatory environment and best strategies for product registration in Kazakhstan
15.10 Panel Session: Sharing practical experience of submissions in the CIS countries
14.00 How eCTD & IDMP Will Work Together
14.35 Label and Artwork Management Systems: Transitions and Sustainability
15.10 Data Structuring Best Practice Case Study
14.00 GCC Experiences with eCTD Transitions and Timelines
14.35 Outlining the Latest Updates from Canada and the Implications for Industry
15.10 Creating a Global Dossier Plan for Fast-Tracking Approvals
15.40 Afternoon Coffee
16.10 Regulatory Affairs for Submissions in Turkey (key updates in turkey; ministry of health, GMP inspections, traceability)
16.45 Practical Outline of European Submissions and Comparison to Emerging Markets
16.10 Developing a Robust Data Archiving System
16.45 Interactive Q&A Panel – All About Data
16.10 Creating a Common Clinical Trials Submission Format
16.45 PANEL: Sharing Experiences of Global eCTD Submissions
17.20 End of day 2
09.10 Updates on the Regulatory Landscape in Brazil
09.45 Industry Experiences of Bringing Products to Market in Brazil
10.20 Examining the Product Registration Landscape in Mexico
09.10 An Update on ICH Q12
09.45 Overview of Variation Types and the Different Procedures for a Marketing Authorisation in the EU
10.20 Demonstrating an Effective Grouping and Work Sharing Strategy
11.25 Case Study: Successfully Registering Products in Argentina
12.00 Biosimilars: Current Status in the Development of Biosimilar Market in LATAM
12.35 Practically Complying with the Evolving Regulatory Landscape in Colombia
11.25 Troubleshooting your EU Filing Variation Plan
12.00 Comparing Requirements: Filing Variation Differences between EU and USA
12.35 Outlining Requirements and Best Practice for Filing Variations in Asia
13.10 Lunch
14.30 Designing an Effective Labelling Strategy for Product Registrations in LATAM
15.05 Panel Session: Latin America Pain Points
14.30 Designing a Successful Global Variation Strategy
15.05 Q & A - Around the World
16.00 End of Filing Variations day
15.30 Afternoon Coffee
16.00 Exploring the Current Efforts for Pharmaceutical Regulation and Harmonisation in Africa
16.30 Regulatory Environment in Gulf Cooperation Council (GCC) Countries
17.00 End of day 3 and close of conference
For speaking opportunities, please contact Sophie Roberts • Sophie.Roberts@knect365.com
For sponsorship opportunities, please contact Luke Pickering • Luke.Pickering@knect365.com