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Informa
08:30 - 09:00 30 mins
Registration
09:00 - 09:10 10 mins
Emerging Markets
Opening remarks from the Chairperson
09:00 - 09:10 10 mins
European Regulatory Affairs Forum
Opening remarks from the Chairperson
09:00 - 09:10 10 mins
eSubmissions and IDMP Compliance
Opening remarks from the Chairperson
09:10 - 09:45 35 mins
Emerging Markets
ANVISA: Exploring the latest regulatory updates
  • Leticia Cafruni - Regulatory Affairs Coordinator, AbbVie, Brazil
more
  • Reviewing latest regulatory updates from ANVISA, including:
  • RDC 73/2016 post approval variations
  • RDC 166/2017 analytical method validation
  • API manual and DMF requirements
  • RDC 171/2017 forced degradation studies
  • Discussing how ANVISA are working to reduce evaluation timelines and benefits for industry
  • Understanding the format and submission of PATE application forms
09:10 - 09:45 35 mins
European Regulatory Affairs Forum
Comparing regulatory requirements and expectations between Europe and the US
  • Paulina Komorowska - Regulatory Affairs Director EMEA, Valeant Pharma, Poland
more
  • Reviewing the latest regulatory landscape in the US
  • Determining how US FDA regulatory requirements compare to Europe, including:
  • Product registration
  • New Drug Applications
  • Pharmacovigilance requirements
  • Discussing whether there is anything specific to be considered for the US which is not required for Europe
09:10 - 09:55 45 mins
eSubmissions and IDMP Compliance
Understanding the long term telematic strategy
  • Remco Munnik - Regulatory Information Director, Asphalion S.L., Spain
more
  • Understanding the long term telematic plan
  • Best practice to create manage all the different data strategies
09:45 - 10:20 35 mins
Emerging Markets
Case study: Practical experience with product registration in Brazil
  • Leticia Cafruni - Regulatory Affairs Coordinator, AbbVie, Brazil
more
  • Best practice for meeting ANVISA’s regulatory requirements and expectations
  • Examining specific challenging requirements in Brazil
  • Success stories
  • Overcoming key challenges
  • Discussing how Brazilian regulatory requirements compare to Europe and the US
09:45 - 10:20 35 mins
European Regulatory Affairs Forum
Exploring comparisons between European and US regulatory requirements and expectations
  • Claudia Hey - Senior Director, Head Europe Global Regulatory and Scientific Policy (GRASP), Merck KGaA, Germany
more
  • Reviewing the latest regulatory landscape in the US
  • Determining how US FDA regulatory requirements compare to Europe, including:

    • New Drug Applications
    • Regulatory Acceleration Procedures (US: Accelerated Approval, Fast track, BTD, Priority review EU: PRIME, Adaptive Pathways concept, accelerated assessment)
    • Clinical Data Transparency in EU and US
  • Discussing whether there is anything specific to be considered for the US which is not required for Europe
09:55 - 10:40 45 mins
eSubmissions and IDMP Compliance
The impact of SPOR on Regulatory affairs
  • Vada A Perkins - Founder and Managing Principal, IDENTIFICA, USA
more
  • Discussing the effect of the SPOR project on CESSP
  • The impact of SPOR on submissions
  • The relationship between SPOR and Master Data Management
10:20 - 10:50 30 mins
Emerging Markets
Spotlight Session by PharmaLex
10:20 - 10:55 35 mins
European Regulatory Affairs Forum
The registration dossier: Best practice for European submissions and comparisons to the emerging markets
  • Anna Roznovska - Head of Global Regulatory Affairs, PRO.MED.CS Praha a.s., Czech Republic
more
  • Highlighting key differences in registration dossier requirements between Europe and the emerging markets, including:
  • Certificate of Pharmaceutical Product (CPP) requirements
  • Country of Origin (COO) requirements
  • Labelling expectations
  • Specific reports and studies
  • Discussing how a solid understanding of the European registration dossier requirements can then be applied to the emerging markets
  • Overcoming key challenges and pitfalls faced
10:40 - 10:55 15 mins
eSubmissions and IDMP Compliance
Question and Answer Panel on the Telematic Strategy and SPOR
  • Remco Munnik - Regulatory Information Director, Asphalion S.L., Spain
  • Vada A Perkins - Founder and Managing Principal, IDENTIFICA, USA
more
10:55 - 11:25 30 mins
Morning Coffee
11:25 - 12:00 35 mins
Emerging Markets
Examining specific requirements for variations in Brazil
  • Darius-Jean Namdjou - International Regulatory Project Lead, Grünenthal GmbH, Germany
more
  • Reviewing variation requirements in Brazil
  • Determining how variation requirements compare to the EU
  • Understanding minor/major variations for different types of change
  • Sharing practical experiences, hints and tips for successful variations in Brazil
  • Overcoming key challenges experienced with variation requirements in Brazil
11:25 - 12:00 35 mins
European Regulatory Affairs Forum
Spotlight Session
  • Spotlight Session - -, -
more
11:25 - 12:00 35 mins
eSubmissions and IDMP Compliance
SPOR Taskforce Feedback: Understanding the Substance Management Service
  • Spotlight Session - -, -
more
  • Outlining the requirements of the Substance Management Service
  • Feedback from the business case study
  • Exploring the timelines for implementation for the SMS
  • Update on the SMS project
12:00 - 12:35 35 mins
Emerging Markets
Case study: Navigating the regulatory environment for product registration in Mexico
  • Stefano Accorsi - Head of Regulatory Affairs “Rest of the World", Chiesi Farmaceutici S.p.A., Italy
more
  • Outlining the latest regulatory frameworks and any recent or upcoming changes
  • Successfully meeting requirements of COFEPRIS
  • Discussing requirements for filing variations in Mexico
  • Reviewing how Mexican regulatory requirements compare to Europe and the US
12:00 - 12:35 35 mins
European Regulatory Affairs Forum
EU pharmacovigilance: Updates on the activities of the PRAC
  • Doris Stenver - Chief Medical Officer and Member, Pharmacovigilance Risk Assessment Committee (PRAC), Danish Medicines Agency, Denmark
more
12:00 - 12:35 35 mins
eSubmissions and IDMP Compliance
FDA feedback on the SRS system and a comparison to SPOR
  • Larry Callahan - Substance Registration System, FDA, USA (presentation to be delivered via teleconference)
more
  • Latest feedback from the FDA on SRS module
  • Understanding the differences between the FDA’s SRS system and SPOR
  • Strategies for being compliant for both SRS and SPOR
12:35 - 13:10 35 mins
Emerging Markets
Case study: Examining Chile’s regulatory environment and successfully registering a product
  • Samuel Bautista - Manager Global Regulatory Affairs, Grünenthal GmbH, Germany
more
  • Outlining latest regulatory requirements and updates
  • Best practice for MAA submissions
  • Comparing regulatory requirements in Chile to the rest of LATAM, Europe and the US
  • Possible changes in regulation for the following years
12:35 - 13:10 35 mins
European Regulatory Affairs Forum
Case study: Implementing successful global variation strategies
  • Meike Vanhooren - Senior Director, Pfizer, Germany
more
  • Aligning different country documentation requirements and expectations
  • Implementing variations across global markets with different approval timelines
  • Determining whether to implement a change in Europe first then globally, or simultaneously
  • Understanding how a global strategy differs from a European strategy
  • Exploring post-approval changes in non-EU countries
12:35 - 13:10 35 mins
eSubmissions and IDMP Compliance
Feedback on the implementation of RMS and OMS
  • Dr Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim, International
more
  • Detailing the success and setbacks of the RMS and OMS implementation
  • Industry feedback of the RMS and OMS stages
  • Future of RMS and OMS with relation to the rest of SPOR
  • Industry integration with eAF
13:10 - 14:30 80 mins
Lunch
14:30 - 15:05 35 mins
Emerging Markets
Case study: Sharing best strategies for clinical trial submissions in Latin America
  • Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
more
  • · Overcoming key challenges faced with clinical trial submissions in LATAM
  • · Outlining the main differing requirements for clinical trial submissions between different LATAM countries
14:30 - 15:05 35 mins
European Regulatory Affairs Forum
Case study: Demonstrating an effective grouping strategy for filing variations
  • Anna Krusińska - Regulatory Manager, AbbVie, Poland
more

· Exploring how a grouping strategy is planned, communicated and implemented

· Outlining the key pros and cons of grouping variations

· Overcoming the challenge of resubmitting all variations if the regulatory authority rejects one within a group

· Discussing grouping fees and whether these can be higher than individual fees

14:30 - 15:05 35 mins
eSubmissions and IDMP Compliance
Feedback on the Products of SPOR
  • Vada A Perkins - Founder and Managing Principal, IDENTIFICA, USA
more
15:05 - 15:40 35 mins
Emerging Markets
Practically implementing pharmacovigilance and risk management activities in LATAM
  • Cristina de Irala, Pharmacovigilance Consultant, Spain
more
  • · Outlining the landscape for pharmacovigilance requirements across LATAM
  • · Reviewing in which regions requirements are increasing
  • · Examining where key implementation challenges lie e.g. ICSRs submission
  • · Exploring requirements for PSUR and Risk Management Plans in LATAM
  • · Comparing requirements in LATAM to Europe and the FDA
15:05 - 15:40 35 mins
European Regulatory Affairs Forum
Case study: Exploring successful worksharing strategies for filing variations
  • Şebnem Türkes Hartwig - Senior Regulatory Affairs Manager, F. Hoffmann-La Roche Ltd., Switzerland
more
  • Outlining how a worksharing strategy was planned, communicated and implemented
  • Examining how worksharing can be used for different types of application procedures (NP, DCP, MRP, CP)
  • Exploring the key challenges experienced with worksharing strategies and how these were overcome
15:05 - 15:40 35 mins
eSubmissions and IDMP Compliance
An introduction to CESSP programme
  • Alastair Nixon - Director, Submission Standards, Global Regulatory Platform and Delivery, GlaxoSmithKline Research & Development Limited, UK
more
  • Context of the requirements of CESSP
  • Timelines for compliance
  • Explaining CESSP requirements for data management
  • CESSP – IDMP the expected synergies and challenges?
15:40 - 16:10 30 mins
Afternoon Tea
16:10 - 17:20 70 mins
Emerging Markets
OPEN FLOOR Q&A DISCUSSION: LATAM
16:10 - 16:45 35 mins
European Regulatory Affairs Forum
OPEN FLOOR Q&A DISCUSSION: European Regulatory Affairs
  • Tânia Veiga - Regulatory Affairs Europe, Orexigen Therapeutics Ireland Ltd.
more
16:10 - 16:45 35 mins
eSubmissions and IDMP Compliance
Outlining the status and timelines of ECTD 4.0
  • Leigh Sandwell - Director, Information Management, Pfizer
more
  • Explaining the basics of ECTD 4.0
  • Update on the status and timeline of ECTD 4.0
  • Examining the impact ECTD 4.0 will have on the submission process
16:45 - 17:20 35 mins
eSubmissions and IDMP Compliance
ELabelling:
more
  • Outline the impact of eLabelling and what it means for industry
  • Overview on the eLabelling pilot
17:20 - 17:55 35 mins
Emerging Markets
Discussing the regulatory pathways for registration of biologics (Vaccines) in LATAM
  • Arturo Gonzalez-Martinez - Senior Regulatory Expert Japan and LATAM, GSK, Belgium
more
  • Life Cycle Management of Vaccines versus small molecule Healthcare products
  • Highlighting what is required for MAA submissions, renewals and variations
  • Outlining the regulatory challenges and expectations for the future
17:20 - 18:30 70 mins
eSubmissions and IDMP Compliance
The future of submission and data management through Automated Intelligence
  • Olga Alfieri - Director, Global Submission Management, GRO, Eisai, USA
more
  • Case study from GSK on automated data management
  • Explaining how automated data management will impact the submission process
  • The potential impact of Automated Intelligence for the submission process
18:30 - 18:35 5 mins
End of Conference Day Two
08:30 - 09:00

Registration

Showing of Streams
10:55 - 11:25

Morning Coffee

Showing of Streams
13:10 - 14:30

Lunch

Showing of Streams
15:40 - 16:10

Afternoon Tea

Showing of Streams
18:30 - 18:35
End of Conference Day Two

End of Conference Day Two