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08:00 09:00 (60 mins)

Main agenda

Registration

09:00 09:10 (10 mins)

Main agenda

Opening remarks from the Chairperson

09:10 09:45 (35 mins)

Global eCTD Management

Sharing practical experiences with eCTD submissions in Saudi Arabia

  • Exploring the latest developments and experiences with submitting eCTD in Saudi Arabia
  • Understanding the complete submission strategy including writing, presenting and submitting a document
  • Reviewing which portions of a document must be submitted via DVD and which on paper
  • Outlining expectations and requirements of the Saudi FDA
  • Praveen Kumar Namala - Senior Officer, Regulatory Affairs, Julphar Gulf Pharmaceuticals Industries, UAE

09:10 09:45 (35 mins)

RIM & IDMP Compliance

Case study: Operating and maintaining an excellent RIM solution in preparation for IDMP

  • Sharing practical experiences with how the project is implemented and operated
  • Understanding how different department systems and processes were integrated
  • Examining how teams should be running a RIMS project after implementation
  • Outlining the impact on regulatory compliance and business outcomes
  • William Mandarino - Associate Director, Product License Knowledge Management, UCB, USA

09:45 10:20 (35 mins)

RIM & IDMP Compliance

Sharing experiences and comparisons of different RIM solutions and discussing opportunities for development of today's solutions

  • Case study: Exploring the lifecycle of a RIM system
  • Examining what is missing in RIM solutions available today
  • Comparing experiences with different RIM systems
  • Nikole Furlotte - Associate Director, bluebird bio, USA

09:45 10:20 (35 mins)

Global eCTD Management

Ministry of Health perspective: Latest updates and progress for eCTD submissions in Oman

  • Tariq Nasser, Ministry of Health, Oman

10:20 10:55 (35 mins)

Global eCTD Management

Exploring latest updates on the go-live for eCTD in South Africa

  • Outlining the latest status of the go-live, MCC updates and expectations for eCTD in South Africa
  • Discussing hints and tips for industry
  • Successfully submitting to and communicating with the MCC
  • Estelle Taute - Director: Operations & Administration, Medicines Control Council, South Africa

10:20 10:55 (35 mins)

RIM & IDMP Compliance

Digital RIM: Leveraging digital technologies to transform Regulatory Information Management

  • Exploring how digital technologies can transform Regulatory Affairs processes and organisations
  • Reviewing examples of digital disruption in other industries and how we can learn from them in Regulatory Affairs
  • Looking beyond Regulatory, how digital and design thinking can re-focus RIM strategies to deliver enterprise wide benefits
  • IDMP as a catalyst, but far from the whole equation
  • John Cogan - VP, Chief Technology Officer, Genpact Pharmalink, UK

10:55 11:25 (30 mins)

Main agenda

Networking and morning coffee

11:25 12:00 (35 mins)

Global eCTD Management

Examining the latest progress towards eCTD submissions in Thailand

  • Clarifying the latest status, agency updates and expectations for eCTD in Thailand
  • Sharing experiences and lessons learnt from Thai eCTD pilot projects
  • Discussing what remains to be addressed for the adoption of eCTD in Thailand
  • Reviewing experiences from the pilot project and comparing them with EU eCTD submissions
  • Jagraj Sangha - Regulatory Operations Associate, Gilead Sciences, UK

11:25 12:00 (35 mins)

RIM & IDMP Compliance

SME case study: Successfully establishing and implementing a RIM project

  • Outlining the scope of the project and defining the business case
  • Examining how internal stakeholders were engaged and support was gained
  • Overcoming key challenges experienced during the transition to a new RIM system
  • RIM capabilities and lessons learnt
  • Moncef Kafi - Head of Regulatory Compliance, GUERBET, France

12:00 12:35 (35 mins)

Global eCTD Management

INTERACTIVE SESSION: China - latest updates and sharing experiences with submitting eCTD

  • Assessing plans for eCTD in China including the development of their own specifications due in 2017
  • Discussing the timelines for eCTD implementation in China
  • Exploring the remaining challenges for the implementation of eCTD in China
  • Comparing requirements and expectations in China with EU eCTD submissions
  • Michel Mikhail, Expert in International Regulatory Affairs and Biosimilars, Germany

12:00 12:30 (30 mins)

RIM & IDMP Compliance

Regulatory 2020 – Technology Fueled Business Transformation

  • Understanding the emerging business drivers of the decade
  • Identifying the future success criteria for Regulatory Affairs
  • Building the 2020 RIM technology landscape to enable this regulatory transformation
  • Pratyusha Pallavi - Product Manager - Regulatory, ArisGlobal, USA

12:35 14:00 (85 mins)

Main agenda

Networking lunch

14:00 14:35 (35 mins)

RIM & IDMP Compliance

Examining what’s in store for the next evolution of RIM

  • Discussing new and emerging technologies for RIM and the benefits for industry
  • Exploring the synergies of RIM and the move toward data submissions (ex: IDMP, eAF, etc.)
  • Exploring the current use and future outlook for cross-divisional RIM programs
  • Reviewing what industry should be thinking about now for RIM, the next key challenges and when to prepare
  • Michelle Charles - Regulatory Implementation, PAREXEL, USA

14:35 15:10 (35 mins)

Global eCTD Management

A use case driven approach to IDMP Master Data Management

  • Nick Lakin - R&D Consulting Head - Europe, Cognizant, UK
  • Leigh Glendinning - Enterprise Data Management Practice Head - UK&I, Cognizant, UK

14:35 15:10 (35 mins)

RIM & IDMP Compliance

Case study: Exploring strategies for data cleaning and to ensure 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
  • Reviewing the key challenges experienced with data cleaning and ensuring high quality data
  • Overcoming these pitfalls and challenges
  • Jens Martin - EU Business Lead Systems, F. Hoffmann-La Roche Ltd, Switzerland

15:10 15:40 (30 mins)

Main agenda

Networking and afternoon tea

15:40 16:15 (35 mins)

Global eCTD Management

Outlining latest updates on the new US Module 1 v2.3 and practical implications for industry

  • Reviewing latest updates from the FDA and timelines for mandatory use of the new version
  • Practical advice for complying with US Module 1 v2.3 and eCTD Validation Criteria v3.1 requirements
  • Overcoming practical challenges presented by US Module 1 v2.3 and eCTD Validation Criteria v3.1
  • Understanding how FDA requests for eCTD submissions compare to Europe and key differences
  • Carrie Mazzrillo - Senior Manager, Global Submission Management, Eisai, USA

15:40 16:15 (35 mins)

RIM & IDMP Compliance

Addressing IDMP Requirements with Navitas and TrackWise – the system you most likely already have

  • Discover a more cost-effective and complete IDMP-ready RIM solution
  • Hear how to simplify and overcome IDMP challenges
  • Learn practical steps to managing your IDMP dataset
  • Gary Aldam - Senior Consultant, Navitas Life Sciences, UK
  • Michael Kline - Senior Solutions Consultant, Sparta Systems, UK

16:15 16:50 (35 mins)

RIM & IDMP Compliance

SME case study: Successfully establishing and implementing a RIM project

  • Outlining the scope of the project and defining the business case
  • Examining how internal stakeholders were engaged and support was gained
  • Overcoming key challenges experienced during the transition to a new RIM system
  • Assessing project outcomes and lessons learnt
  • Nanita Cranford - Sr. Director, Global Regulatory Affairs, Head of Global Regulatory Operations, Jazz Pharmaceuticals, Inc., USA

16:15 16:50 (35 mins)

Global eCTD Management

Regulatory agency perspective: Feedback, plans and practical advice for eCTD submissions

  • Outlining current agency priorities and future plans
  • Understanding how industry data is handled and how eCTDs are being processed
  • Exploring where focus has been made on the EU eSubmissions Roadmap
  • Reviewing expectations and requirements for industry eCTD submissions
  • Common mistakes seen with submissions and why they have been rejected
  • José Manuel Simarro Escribano - IT Director, Agencia Española de Medicamentos y Productos (AEMPS), Spain

16:50 18:30 (100 mins)

Main agenda

End of conference day one and networking drinks