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DAY TWO - CET (Central European Time, GMT+1)
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DAY TWO - CET (Central European Time, GMT+1)
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09:55 - 10:005 mins
IDMP Focus Day
Opening Remarks from Chair
09:55 - 10:005 mins
Global eSubmissions
Opening Remarks from Chair
09:55 - 10:005 mins
Regulatory Affairs in Latin America
Opening Remarks from Chair
10:00 - 10:4040 mins
IDMP Focus Day
Interview with Members of IDMP Taskforce
- Laurent Desqueper - XEVMPD & IDMP Business System Owner, MSD Europe Inc, Germany
- Ana López De La Rica Manjavacas - International and EU Affairs Division, AEMPS, Spain
10:00 - 10:4040 mins
Global eSubmissions
Interview with Members of IDMP Taskforce
- Laurent Desqueper - XEVMPD & IDMP Business System Owner, MSD Europe Inc, Germany
- Ana López De La Rica Manjavacas - International and EU Affairs Division, AEMPS, Spain
10:00 - 10:4040 mins
Regulatory Affairs in Latin America
LATAM – Access to Innovation, Harmonization, Convergence, Reliance
- Belkis Romeu - Manager Office of Innovation, Cuban Regulatory Authority – CECMED
- Lawrence Liberty - Director, Centre International Regulatory Sciences (CIRS)
- Mario Alanis - Senior Consultant, Centre International Regulatory Sciences (CIRS)
10:45 - 11:1025 mins
IDMP Focus Day
IDMP More than a Requirement: Business Benefits.
- Quentin Grignet - Director – Master Data Strategy & Analytics, IDMP Program Sponsor, GSK, Belgium
10:45 - 11:1025 mins
Global eSubmissions
Status, Timelines and Requirements of eCTD 4.0
10:45 - 11:1025 mins
Regulatory Affairs in Latin America
Brazil: Best Regulatory Strategies, Market Access and Reimbursement
- Arturo Gonzalez-Martinez - Senior Regulatory Expert Japan and LATAM, GSK, Belgium
11:15 - 11:4530 mins
IDMP Focus Day
Interactive Session: Preparing for IDMP Implementation
- Margo Tyler-Mcwilliams - Associate Director, Regulatory Informatics and Analytics Global Regulatory Operations, Takeda
- Patrick Middag - Information Technology Business Partner Regulatory IDMP Associate Director, Bristol-Myers Squibb, Belgium
- Laurent Lefebvre - Regulatory CMC Associate Director - RA, Novartis Pharma AG
11:15 - 11:4530 mins
Global eSubmissions
eCTD V4: Industry Experience in Swiss and EU
- Shakul Hameed - Associate Director - Lead - Regulatory Information Management & Technologies, Takeda
11:15 - 11:4530 mins
Regulatory Affairs in Latin America
Brazil: Regulatory Framework - APIs
- Ronaldo Lucio - General Manager of Inspections, ANVISA
11:50 - 12:1525 mins
IDMP Focus Day
Session from Calyx
- Karen Harry - Director, Regulatory Implementation, Calyx
11:50 - 12:1525 mins
Global eSubmissions
eCTD 4.0 with EXTEDO
- Frank Dickert - Senior Business Consultant, EXTEDO
11:50 - 12:1525 mins
Regulatory Affairs in Latin America
Examining Brazil’s Harmonization Efforts
- Antonio Barra Torres - President, ANVISA
12:15 - 13:1560 mins
Networking Break including IDMP Platform Solutions
13:15 - 13:4025 mins
IDMP Focus Day
Spotlight Session
13:15 - 13:4025 mins
Global eSubmissions
Understanding how Submission of More Product Data as Structured Data could Impact the eCTD Dossier Process’.
- Andreas Franken - Data Officer, B.A.H.
13:15 - 13:4025 mins
Regulatory Affairs in Latin America
Brazil: Orphan Drug Registration - Strategic Regulatory Pathway
- Solange Nappo - Regulatory Affairs Director, Interfarma
13:45 - 14:1025 mins
IDMP Focus Day
Sharing Experiences with Integrating Different Systems for IDMP
- Stephen Blanchard - IDMP Programme Lead, Johnson & Johnson Consumer EAME, UK
13:45 - 14:1025 mins
Global eSubmissions
Data vs Documents: Regulatory Affairs Impact
- Alastair Nixon - Director, Submission Standards, Global Regulatory Platform and Delivery, GlaxoSmithKline Research & Development Limited, UK
13:45 - 14:1025 mins
Regulatory Affairs in Latin America
Mexico: Overview- Regulatory landscape & Market Access
- Julio Sánchez y Tépoz - President, ALo Prosciences / Former Federal Commissioner - COFEPRIS
14:15 - 14:5540 mins
IDMP Focus Day
Implementing IDMP on a Time Crunch
- Costas Mistrellides - IDMP Regulatory Affairs Co-Ordinator, Merck Group
14:15 - 14:5540 mins
Global eSubmissions
IDMP/ eCTD Interactive Surgery
- Joel Finkle - Associate Director, Regulatory Information Management, BeiGene, Ltd
14:15 - 14:5540 mins
Regulatory Affairs in Latin America
Colombia: Regulatory Overview and Drug Registration
14:55 - 15:5560 mins
Networking Break including Roundtables
15:55 - 16:2025 mins
IDMP Focus Day
Practical Advice on Being Prepared to Migrate from EVMPD to IDMP
- Mandy Mason - Associate Director, Data Stewardship & Compliance, BMS
15:55 - 16:2025 mins
Global eSubmissions
Responding to a Pandemic, the Regulatory Operations Experience
- Jack Daley - Manager, Regulatory Operations, Gilead Sciences, UK
15:55 - 16:2025 mins
Regulatory Affairs in Latin America
Pharmacovigilance and Risk Management in LATAM
16:25 - 16:5025 mins
IDMP Focus Day
Ensuring data compliance for ‘Legacy’ Products under IDMP and other telematic programmes
- Argha Nag - Global Regulatory Systems & Data Governance Lead, AstraZeneca
16:25 - 16:5025 mins
Global eSubmissions
Automation for Submissions
- Dr Katharina Schmitz - Head of Automator Solutions, LORENZ Life Sciences Group
16:25 - 16:5025 mins
Regulatory Affairs in Latin America
How has COVID-19 Affected the LATAM Region and the Regulatory Landscape?
- Julio Sánchez y Tépoz - President, ALo Prosciences / Former Federal Commissioner - COFEPRIS
- Belkis Romeu - Manager Office of Innovation, Cuban Regulatory Authority – CECMED
- Lawrence Liberty - Director, Centre International Regulatory Sciences (CIRS)
- Mario Alanis - Senior Consultant, Centre International Regulatory Sciences (CIRS)
16:50 - 16:555 mins
END OF CONFERENCE DAY 2
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