Regulatory Information Management

Transcription

1 Regulatory Information Management Hotel Meliá Avenida América, Madrid Day 1 - Tuesday 26 April :30-09:00 Conference Registration 09:00-09:10 Opening remarks from the Chair RIM Practical Insight and Benchmarking 09:10-09:45 Determining a new RIM Introduction of company situation Prerequisites before getting started Preparations & follow ups Execution of the actual search round one Analyses of results & first decisions Execution of detailed examinations - final round Implementation decision Best practices Conclusion Andreas Derksen, Subject Matter Lead Reg. Mgmt. & Data Analytics, Mylan Healthcare GmbH 09:45-10:20 Case study: Exploring the process and practical challenges of implementing and operating a successful RIM project Clarifying the scope and objectives of the RIM project Sharing experiences with how the project was implemented and operated in practice Understanding how different department systems and processes where integrated Evaluating methods to speed up the process for implementing a RIM system Assessing the impact on regulatory compliance and business outcomes Quentin Darrasse, Global Regulatory Operations Quality Manager, Hoffman-La Roche Ltd. 10:20-10:55 Case study: Exploring the operational process for running and managing a successful RIMS project Examining how teams should be running a RIMS project after implementation Determining whether the project should be managed as a centralised or decentralised model Overcoming key challenges experienced with the operational process Key lessons learnt Gillian King, Senior Director, Submission Sciences, Regulatory Affairs, Biogen Idec Ltd. 10:55-11:25 Networking and morning coffee 11:25-12:00 Understanding the benefits and advantages of RIM systems for overall company objectives

2 Outlining how RIM can increase company efficiencies Examining how increased efficiencies from RIM can be measured Determining to what extent RIM can improve regulatory compliance Reviewing how RIM can impact the competitiveness of an organisation Erik Hill, Sr. Director, Head, GRO, Global Regulatory Affairs CFU, Eisai, Inc. 12:00-12:35 Presentation to be delivered by Cunesoft 12:35-13:35 Networking lunch 13:35-14:10 Case study: Exploring the movement of management of ROW core dossiers into a RIM system Outlining the process involved Overcoming the practical challenges Lisa Owens, Senior Manager Regulatory Operations, Gilead Sciences Integrating Other Department Systems 14:10-14:45 Interactive Round Tables: Sharing experiences with integrating other department systems for effective RIM Experience Exchanges are interactive sessions where attendees can share their questions and knowledge. Attendees will be split into small groups to share experiences and solutions to common problems in an informal environment. Joe Baldari, Manager, Global Regulatory Systems, CSL Behring 14:45-15:20 Presentation to be delivered by GENPACT Pharmalink 15:20-15:50 Networking and afternoon tea Labelling, CMC Changes and RIM 15:50-16:25 Strategies for tracking labeling and CMC changes in RIM to support IDMP Aligning RIM with document management and change control systems Balancing global responsibilities vs. local responsibilities Moving RIM towards more structured content Facilitating medicinal product release with RIM information William Mandarino, Associate Director, Product License Knowledge Management, UCB 16:25-17:00 Case study: Best practice for integrating CMC changes into RIM systems Clarifying how CMC changes should be integrated and coordinated into RIM systems Examining the key challenges experienced when integrating a CMC system into a RIM system Practical advice for overcoming these challenges Manfred Ruchti, Assoc. Dir. Submission Management, Merck Serono

3 17:00-18:00 Networking drinks 18:00-19:15 Regulatory Information Management Evening Experience Exchange This extended session will allow industry to share experiences and solutions to key challenges encountered during RIM implementation projects. Grab yourself a drink and some tapas from the drinks reception and move freely between the discussion tables listed below. Participants are encouraged to bring company cases and current challenges to discuss with industry peers and experts. Discussion areas include: Operational process for running and managing a successful RIMS project Benefits and advantages of RIM systems for overall company objectives Integrating CMC changes into RIM systems Effective RIMs processes by streamlining and ensuring efficient data entry MDM and solving IDMP challenges Gillian King, Senior Director, Submission Sciences, Regulatory Affairs, Biogen Idec Ltd. Erik Hill, Sr. Director, Head, GRO, Global Regulatory Affairs CFU, Eisai, Inc. Manfred Ruchti, Assoc. Dir. Submission Management, Merck Serono Sarah Tindall, Regulatory Information Manager, Johnson & Johnson Susanne Koch, IDMP IT Program Lead, Boehringer Ingelheim Pharma GmbH & Co. KG 19:15-19:15 End of day one Day 2 - Wednesday 27 April :00-09:10 Opening remarks from the Chair Data Standardisation and Harmonisation 09:10-09:45 Case study: Best strategies for data cleaning and ensuring high quality data across the business Ensuring effective data cleaning when migrating from one system to another or altering significant systems Understanding the importance of data cleaning for IDMP preparation Assessing the key challenges experienced with data cleaning and ensuring high quality data Overcoming these pitfalls and challenges Joe Baldari, Manager, Global Regulatory Systems, CSL Behring 09:45-10:20 Establish effective RIMs processes by streamlining and ensuring efficient data entry Best strategies to ensure data is entered correctly without errors Determining how to enter data in a timely and efficient manner Understanding how to ensure data quality whilst also ensuring data ownership is clear Clarifying user requirements and roles within the application, Sarah Tindall, Regulatory Information Manager, Johnson & Johnson

4 including affiliates and across regulatory affairs 10:20-10:55 Presentation to be delivered by INFOTEHNA 10:55-11:25 Networking and morning coffee 11:25-12:00 Working in harmony to attain and maintain data quality for RIM Dimensions of data quality Impact of data entry models on data quality Leveraging the cooperation framework across the organisation to ensure high data quality Executing a data quality initiative and maintaining data quality after the fact Danielle Beaulieu, Director, Global Regulatory Business Capabilities, Bristol-Myers Squibb RIM and the Future 12:00-12:35 Exploring future plans and perspectives for Regulatory Information Management Representative speaker from PAREXEL, Understanding the potential for RIM as a commercial tool to drive business decision making Reviewing latest technological advancements for the interest of RIM Examining the current use and future outlook for crossdivisional RIM programs for different product types Clarifying what industry should be thinking about now for RIM, the next key challenges and when to prepare 12:35-13:35 Networking lunch Master Data Management and RIM 13:35-14:10 Case study: Best strategies for implementing Master Data Management (MDM) and the single source of truth Discussing MDM as a prerequisite for functional integration Understanding how MDM can be used to integrate requirements and solutions from different departments Ensuring different departments are engaged and understand the benefits of MDM Exploring the impact of a single source of truth on processes and efficiencies Outlining the benefits of MDM as a prerequisite for IDMP Guido Claes, Drug Development Master Data Management, Janssen Pharmaceuticals Cloud Solutions and RIM 14:10-14:45 Outlining the practicalities, benefits and pitfalls of using cloud systems in regulatory operations Assessing concerns around compliance and data security with cloud systems Best practice for day-to-day implementation and overcoming key challenges Successfully integrating cloud systems with existing tools and systems Reviewing key advantages and disadvantages seen by companies using cloud solutions

5 14:45-15:15 Networking and afternoon tea Breaking Silos and Effective System Integrations 15:15-15:50 Case Study: How to break silos and make effective system integrations Zhiguang Deng, Senior System Manager, Global Pharmacovigilance, LEO Pharma A/S Data Standardisation and Harmonisation Panel 15:50-16:25 Top Table Panel Discussion: Best practice for managing data and data quality during RIM implementation Who owns the data and how can data ownership be made clear whilst ensuring data quality? Who is in the best position to manage data input? Where should responsibilities lie to ensure high quality data? How are centralised and decentralised RIM models implemented to ensure high quality data? 16:25-16:25 End of conference day two IDMP day 3 - Thursday 28 April :00-09:10 Opening remarks from the Chair Latest Status and Updates IDMP 09:10-09:45 Exploring the current status and timelines associated with a mandatory date for IDMP implementation in Europe Outlining the EMA roadmap for IDMP implementation Reviewing the phased approach to IDMP implementation and impact on industry Clarifying the status of postponement of the July 2016 deadline Determining how the ISO standards will be interpreted and implemented Examining the current situation and timelines for the ISO IDMP implementation guides and supporting vocabularies Andrew P Marr, Managing Director, Marr Consultancy Ltd. 09:45-10:20 FDA perspective: Defining and registering substances and the use of substance ID to define products that are compliant with IDMP Exploring the Global Ingredient Archival System (GInAS) Understanding the Global Substance Registration System (GSRS) Larry Callahan, Substance Registration System, FDA [to be confirmed] 10:20-10:55 Assessing the IDMP implementation guides: Overview, current status and timelines Overview and explanation of the IDMP implementation guides Reviewing the concepts and conventions used in the IDMP implementation guides Examining the timelines involved and current availability of Barry Hammond, Managing Director, Terminologeze Ltd.

6 IDMP implementation guides and supporting vocabularies Assessing the impact on industry 10:55-11:25 Networking and morning coffee 11:25-12:00 Presentation to be delivered by GENPACT Pharmalink IDMP Practical Considerations 12:00-12:35 Case study: Understanding the strategies and key challenges associated with getting an IDMP project started Best practice and recommendations for getting an IDMP project started Exploring how the project was set up and where the governance is located in the company Reviewing how the understanding and implications of IDMP are spread to internal stakeholders Overcoming key challenges with IDMP project start-up Barbara Rangetiner, General Manager & Director International Drug Regulatory Affairs, Octapharma Pharmazeutika ProduktionsgesmbH 12:35-13:10 Best strategies for successfully incorporating IDMP into an existing RIM system Understanding the process of how to incorporate IDMP into an existing RIM system Outlining the importance of a RIM system supporting IDMP Assessing the need for a RIM system to allow for the generation of new and updated IDMP messages Overcoming key challenges faced when integrating IDMP into a RIM system Andrea Obermeyer, Vice President, arivis AG 13:10-14:10 Networking lunch 14:10-14:45 Presentation to be delivered by NNIT 14:45-15:20 Case study: Ensuring analytical data quality for IDMP using data standards Best strategies for collecting all data from different laboratory systems for IDMP Examining how data is linked together with no gaps Making sure that data is correct and in the appropriate format The Allotrope Framework as a Taxonomy provider for analytical data Gerhard Noelken, Business IT Lead Science, Pfizer XEVMPD to IDMP 15:20-15:55 Successfully managing the transition from XEVMPD to IDMP Exploring an overview of the current status of XEVMPD Providing clarification of the transition process: What important steps are required? Reviewing the migration of XEVMPD data into IDMP Examining tools and systems which can be used for support in Christine Hirt, Managing Consultant, EXTEDO

7 the transition process Outlining where lessons learnt from XEVMPD can be applied to IDMP 15:55-16:25 Networking and afternoon tea Master Data Management Approach Towards IDMP Compliance 16:25-17:00 How to solve the IDMP challenges with a Master Data Governance approach Understanding the Master Data Governance Framework in the context of Enterprise Architecture Outlining the utilisation of the Framework for the IDMP compliance solution Gaining insight about the recent IDMP program achievements at BI Susanne Koch, IDMP IT Program Lead, Boehringer Ingelheim Pharma GmbH & Co. KG 17:00-17:35 Case study: Using MDM through the use of business rules, Standard Value List, and a QC process to help ensure data quality John Polhemus, Director, RQS Information Services and Data Governance Office, AbbVie IDMP Experience Exchange 17:35-18:10 Interactive Experience Exchange: Sharing experiences with implementation of IDMP projects Experience Exchanges are highly interactive sessions where attendees can share their questions and knowledge. Attendees will be split into small groups to share experiences and solutions to common problems in an informal environment. What different approaches are companies taking for successful implementation? What phases of implementation are other companies in? What common challenges and opportunities are seen with implementation? What does the guidance really mean in practice?