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08:30 - 09:00 30 mins
Main agenda
Registration
09:00 - 09:10 10 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Opening Remarks from the Chairperson
  • Malika Almansouri - Vaccine Global Regulatory Affairs: Region Expert (India-Russia-CIS-MENA), GSK Vaccines, Belgium
more
09:00 - 09:10 10 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Opening Remarks from the Chairperson
  • Lamine Messaoudi - Co-Founder, RegArise, USA
more
09:00 - 09:10 10 mins
Global eSubmissions
Opening Remarks from the Chairperson
  • Suzie Henderson - Regulatory/Senior Operations Manager, Indivior, UK
more
09:00 - 09:10 10 mins
Biosimilars
Opening Remarks from the Chairperson
  • Arno Kromminga - Chief Scientific Officer (CSO)/Senior Vice President, IPM Biotech/BioAgilytix, Germany
more
09:10 - 09:45 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Regulatory environment in Gulf Cooperation Council (GCC) countries, including centralised procedure model, national procedures and degree of harmonisation
  • Abdul Mateen - Regulatory Affairs Consultant, AstraZeneca, UK
more
  • Clarifying the current status of the centralised registration procedure in the GCC and overview of how it works
  • Overview of national registration procedures in GCC region and comparison with centralised procedure
  • Exploring legislation changes in the region including eCTD implementation
  • Practical advice when registering in the GCC region, including documentation requirements and timelines
  • Company registrations, tenders and LCM activities in GCC
  • Best practice for working with agents and distributors for registration in the GCC
  • Overcoming key challenges experienced with drug registrations in the GCC
09:10 - 09:45 35 mins
Biosimilars
Best practice strategies for designing and conducting clinical trials for biosimilars
  • Ekkehard Brockstedt - TCM Biosimilars, Global Clinical Operations, Boehringer Ingelheim, Germany
more
  • Considerations in early clinical development
  • Factors to be included in designing a clinical trial development for Biosimilars
  • Challenges in clinical operations
  • Best operational procedure to minimize cost and maximize result
09:10 - 09:45 35 mins
Global eSubmissions
Exploring the impact of the EU Telematics Programme from EM EU TMB on eSubmissions (eCTD)
  • Ulrike Vollmer - Regulatory Submission Management, Bayer AG, Germany
more
09:10 - 09:45 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Understanding and implementing pharmacovigilance and risk management requirements in Asia-Pacific
  • Stewart Geary - Deputy Director, Eisai, Japan (presentation to be delivered via teleconference)
more
  • Exploring which countries have increasing requirements for pharmacovigilance
  • Best practice for managing pharmacovigilance activities in Asia-Pacific
  • Reviewing requirements in place for PSURs, tracking and reporting
  • Clarifying requirements for Risk Management Plans
  • Outlining the degree to which Asia-Pacific has aligned requirements to Europe and the US
09:45 - 10:20 35 mins
Global eSubmissions
Eisai case study: Adapting & aligning internal eCTD operational processes with EMA Policy 70
  • Wil Foster - Director Regulatory Affairs – Operations, Eisai Limited, UK
more
  • Reviewing the impact EMA Policy 0070 will have on industry, including key concerns and challenges to date
  • Understanding how redacted clinical study reports align with the actual eCTD lifecycle of a product
  • Exploring available related guidance and implications for industry
  • Assessing the operational challenges and pitfalls associated with these requirements
09:45 - 10:20 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Regulatory update and practically meeting requirements for registration in Kuwait and Qatar
  • Syndie Messager - Market Access and International Regulatory Affairs Coordinator, Laboratorios Cinfa, Spain
more
  • Outlining the current regulatory framework and any upcoming changes
  • Reviewing best strategies for lifecycle management in Kuwait and Qatar
  • Best practice for submission, including documentation requirements and timelines
  • Working successfully with agents and distributors for registration
  • Exploring key regulatory pitfalls and practical advice on how these can be overcome
09:45 - 10:20 35 mins
Biosimilars
Exploring best strategies for designing and conducting global clinical trials
  • Uwe Gudat - Head of Safety Biosimilars, Merck, Switzerland
more
  • Outlining requirements and expectations for biosimilar trials across the globe
  • Understanding use of a global reference product
  • Best practice for using historical data to design clinical trials
  • Overcoming key challenges with designing and conducting clinical trials
09:45 - 10:20 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Understanding orphan drug designation requirements and expectations in Japan
  • Lamine Messaoudi - Co-Founder, RegArise, USA
more
10:20 - 10:55 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Regulatory update and practically meeting requirements for registration in Jordan: Jordan FDA perspective
  • Wesal Haquaish - Head Drug Registration Dept, Jordan FDA, Jordan
more
10:20 - 10:55 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Overview of post approval changes and amendments to marketing authorisations. Nuances in variations from EMA & MHRA and Australian applications
  • Gordon Elger - Senior Advisor, UL Compliance to Performance, USA
more
  • Introduction to UL Compliance To Performance
  • Overview of regulatory framework in Australia and highlighting differences from other regulatory bodies especially the EU
  • Post approval changes and categorisation into the different types & categories compared to the EU approach 
  • Quality Change – A practical example of a typical quality change and a review of EU requirements
  • Comparison to the EU post approval changes (variations) guidance 
10:20 - 10:55 35 mins
Biosimilars
Understanding the effective assessment and comparison of Critical Quality Attributes (CQA) to establish biosimilarity
  • James Anderson - Senior Vice President of Pharmaceutical Sciences, Momenta Pharmaceuticals, Inc., USA
more
  • Determining how criticality is assigned to specific attributes
  • Outlining approaches to assessing the significance of differences in CQAs
  • Reviewing approaches to attributes for which clinical studies lack sensitivity
  • Examining and comparing the way in which CQA are assessed in Europe and the US
10:55 - 11:25 30 mins
Main agenda
Networking and Morning Coffee
11:25 - 12:00 35 mins
Global eSubmissions
PANEL DISCUSSION: End to End Labeling in a Multilingual World
  • Diana Guarin - Regulatory Affairs Director, AbbVie Inc., USA
  • Patrick Middag - Associate Director, Regulatory IT, Bristol-Myers Squibb, Belgium
  • Eric Jacobs - VP Life Sciences Strategy, SDL, UK
more
11:25 - 12:00 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Overcoming regulatory challenges in Africa
  • Malika Almansouri - Vaccine Global Regulatory Affairs: Region Expert (India-Russia-CIS-MENA), GSK Vaccines, Belgium
more
  • Regulatory challenges in Africa
  • Update on harmonisation initiatives
11:25 - 12:35 70 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
ASIA-PACIFIC COLLABORATION ZONE
  • Joe Zhou - CEO, Genor BioPharma, China
  • Ann-Lisbeth Aarup Nielsen - Senior Regulatory Affairs Specialist, ALK-Abelló A/S, Denmark
  • Justyna Kwiatkowska - Junior Regulatory Affairs Specialist, Adamed Group, Poland
  • Eric Ducamp - Associate Director, Global Regulatory Affairs, Ipsen, France
more

Save your questions from the session and join a round table dedicated to your region of choice. Join the speaker and other attendees as they share experiences on the challenges faced in a highly interactive environment.

Round table 1: China

Round table 2: South Korea

Round table 3: Taiwan

Round table 4: ASEAN countries

11:25 - 12:00 35 mins
Biosimilars
Overcoming the challenge of indication extrapolation for mAb biosimilars
  • Nicole Filser - Independent Consultant, VORCET, Switzerland
more
  • Exploring the regulatory basis for indication extrapolation
  • Discussing whether enough data is being generated to extrapolate indications
  • Outlining clinical considerations for extrapolation of indications, including:
    • Clinical comparability
    • Mechanism of action
    • Immunogenicity
    • PK & PD
12:00 - 12:35 35 mins
Biosimilars
Practically developing and validating immunogenicity assays for biosimilar drug development
  • Arno Kromminga - Chief Scientific Officer (CSO)/Senior Vice President, IPM Biotech/BioAgilytix, Germany
more
  • Understanding regulatory authority requirements and expectations for immunogenicity assays
  • Determining how immunogenicity should be reported to the regulatory authorities
  • Exploring any new and updated requirements for immunogenicity assays
  • Case examples of successful immunogenicity assay development and validation
12:00 - 12:35 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Reviewing the country-specific labelling and packaging requirements in MENA
  • Parminder Kaur - Founder and RA/PV Consultant, RegPak BioPharma Consulting, The Netherlands
more
  • Exploring the country-specific requirements in MENA for labelling and packaging
  • Understanding the extent to which MENA depends on and compares to foreign labels
  • Discussing how country-specific requirements creates increased workload and expenses for industry
  • Overcoming key challenges with company-specific labelling and packaging requirements in MENA
12:00 - 12:35 35 mins
Global eSubmissions
Global submission reuse
  • Jack Daley - International Regulatory Publishing Associate II, Gilead Sciences, UK
more

A detailed tour of Gilead’s Global reuse publishing process from NDA to RoW, covering both the benefits, challenges and the lessons learned from our strategy.

12:35 - 14:00 85 mins
Main agenda
Networking Lunch
14:00 - 14:35 35 mins
Biosimilars
Proposing abbreviated development pathways for biosimilars
  • Hubert Chen - Chief Medical Officer, Pfenex, USA
more
  • Understanding regulatory authority requirements and expectations for clinical endpoints
  • Strategies in negotiating and designing abbreviated PK, PD and immunogenicity studies
  • Case examples of successful abbreviated development programs
14:00 - 15:10 70 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
TURKEY AND MENA COLLABORATION ZONE
  • Abdul Mateen - Regulatory Affairs Consultant, AstraZeneca, UK
  • Syndie Messager - Market Access and International Regulatory Affairs Coordinator, Laboratorios Cinfa, Spain
  • Malika Almansouri - Vaccine Global Regulatory Affairs: Region Expert (India-Russia-CIS-MENA), GSK Vaccines, Belgium
  • Deniz Cigdem AKYÜREK - Regulatory Affairs & Market Access Director, Abdi Ibrahim Pharmaceuticals, Turkey
more

Save your questions from the session and join a round table dedicated to your region of choice. Join the speaker and other attendees as they share experiences on the challenges faced in a highly interactive environment.

Round table 1: GCC

Round table 2: Kuwait / Qatar

Round table 3: Africa

Round table 4: Turkey 

14:00 - 14:35 35 mins
Global eSubmissions
Ensuring a robust global submissions strategy and practically managing global changes presented by the adoption of eCTD
  • Suzie Henderson - Regulatory/Senior Operations Manager, Indivior, UK
more
  • Discussing how EU or US dossiers can be reused for emerging market submissions
  • Reviewing how much of the submission process should be completed centrally and how much by local affiliates
  • Establishing teams and processes to ensure agility and the ability to respond to external changes
  • Exploring preparation and responses to new countries and regions adopting eCTD
14:00 - 14:35 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Health agency interactions in Latin America; available possibilities, timings of advice and its impact on overall regulatory strategy
  • Ayaz Khan - Director, Regulatory Affairs, Grünenthal GmbH, Germany
more
14:35 - 15:10 35 mins
Biosimilars
INTERACTIVE PANEL DISCUSSION: Overcoming non-clinical hurdles in the development of biosimilars
  • Hubert Chen - Chief Medical Officer, Pfenex, USA
  • Arno Kromminga - Chief Scientific Officer (CSO)/Senior Vice President, IPM Biotech/BioAgilytix, Germany
more
  • What is the minimum quantity of non-clinical testing needed to satisfy the regulatory authorities?
  • To what extent can biosimilars differ from the innovator during non-clinical studies?
  • How can immunogenicity assays be developed and validated for biosimilar drug development?
  • How can regulatory expectations be translated into clinical studies?
  • What are the regulatory expectations for non-clinical PK and ADA assays?
14:35 - 15:10 35 mins
Global eSubmissions
On boarding new countries into eCTD. Lessons learnt and future demand
  • Jens Pantke - Team Leader Regulatory Submission Group Basel, F. Hoffmann-La Roche Ltd., Switzerland
more
14:35 - 15:10 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Understanding and implementing pharmacovigilance and risk management activities in Latin America
  • Cristina de Irala, Pharmacovigilance Consultant, Spain
more
  • Determining which countries have increasing requirements for pharmacovigilance
  • Best practice for managing pharmacovigilance activities in Latin America
  • Exploring requirements in place for PSURs, tracking and reporting
  • Outlining requirements for Risk Management Plans in Latin America
  • Reviewing the degree to which Latin America has aligned requirements to Europe and the US
15:10 - 15:40 30 mins
Main agenda
Networking and Afternoon Tea
15:40 - 16:15 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Case study: Overcoming the challenge of GMP inspections in Turkey
  • Deniz Cigdem AKYÜREK - Regulatory Affairs & Market Access Director, Abdi Ibrahim Pharmaceuticals, Turkey
more
  • Understanding the regulatory guidance available for GMP site audits
  • Addressing the long timelines involved with GMP site audits and how long it takes to get approval afterwards
  • Exploring the documentation which must be prepared for GMP site audits and other specific requirements
  • Reviewing whether and when procedures for GMP inspections in Turkey will change
15:40 - 16:15 35 mins
Biosimilars
Practically carrying out “fingerprint”-like analysis for effective biosimilar characterisation
  • Gabriela Ridner-Bahar - Principal Scientist, Bio Analytical Development, Teva, Israel
more
  • Outlining regulatory authority expectations for finding fingerprints of biosimilars
  • Best strategies for demonstrating similarity in terms of physicochemical and biological quality attributes
  • Discussing whether there are any statistical models available, which take into account multiple Critical Quality Attributes to determine biosimilarity
  • Overcoming key challenges experienced
15:40 - 16:15 35 mins
Global eSubmissions
Exploring latest developments towards eCTD across the Gulf Cooperation Council (GCC)
  • Abid Hussain - Senior Manager Regulatory Affairs, Emcure pharmaceuticals Ltd., UAE
more
  • Latest updates and timelines for eCTD in the GCC
  • Sharing experiences with mandatory eCTD submissions in the GCC
  • Discussing requirements and practically preparing for mandatory baseline eCTD submissions in the GCC
  • Comparing experiences with eCTD submissions in the GCC region to EU and any additional requirements
15:40 - 16:15 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
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
16:15 - 16:50 35 mins
Biosimilars
Why does Hercule Poirot like biosimilars?
  • Uwe Gudat - Head of Safety Biosimilars, Merck, Switzerland
more
  • Exploring the “Totality of Evidence
  • Understanding how the interrelationships between structure, analytical characterization and limited clinical evidence create a strong case in support of a biosimilar product
16:15 - 16:20 5 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
End of Emerging Markets Stream 1 Day Three
16:15 - 16:50 35 mins
Global eSubmissions
China: Latest updates and sharing experiences with submitting eCTD
  • Carolline Petersen - Project Manager, Novo Nordisk A/S, Denmark
more
  • Assessing plans for eCTD in China and any guidance available
  • 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
16:15 - 16:20 5 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
End of Emerging Markets Stream 2 Day Three
16:50 - 17:25 35 mins
Global eSubmissions
Latest updates and progress for eSubmissions in Jordan
  • Wesal Haquaish - Head Drug Registration Dept, Jordan FDA, Jordan
more
16:50 - 16:55 5 mins
Biosimilars
End of Biosimilars Day Three
17:25 - 17:30 5 mins
Main agenda
End of Conference Day Three