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08:00 - 09:00 60 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
  • Alex Dranov - Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe, GmbH & Co. KG, Germany
more
09:00 - 09:10 10 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Opening Remarks from the Chairperson
  • Stefano Accorsi - Head of Regulatory Affairs “Rest of the World", Chiesi Farmaceutici S.p.A., Italy
more
09:00 - 09:10 10 mins
IDMP Compliance
Opening Remarks from the Chairperson
  • Andrew P Marr - Managing Director, Marr Consultancy Ltd., UK
more
09:00 - 09:10 10 mins
Biosimilars
Opening Remarks from the Chairperson
  • Richard Peck - Vice President / Regulatory Affairs, Lupin, Switzerland
more
09:10 - 09:45 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Case study: Best practice for making an application for a GMP inspection in order to receive Russian GMP conclusion
  • Prasanna Kumar Thenneti - Head, Regulatory Affairs – Emerging Markets, Dr. Reddy’s Laboratories, India
more
  • Outlining the application process and challenges encountered along the way
  • Clarifying who the application should be sent to
  • Understanding the timelines and how long the application process should take
  • Practical advice for ensuring that the process is as fast and simple as possible
09:10 - 09:45 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Understanding the latest regulatory framework in Brazil and best strategies for product registration
  • Carlos Thomazini - Regulatory Affairs & Quality Director, AbbVie Farmacêutica Ltda., Brazil
more
  • Current regulatory environment and any recent or upcoming changes
  • Overcoming key challenges with product registration in Brazil
  • Working successfully with ANVISA
09:10 - 09:45 35 mins
IDMP Compliance
Latest status of IDMP and EMA timelines for Iteration 1
  • Andrew P Marr - Managing Director, Marr Consultancy Ltd., UK
more
  • Clarifying the current status and timelines associated with:
    • Start of implementation of Iteration 1 for Products and Substances
    • Enforcement of Iteration 1 for Products and Substances
  • Current and potential future iterations and their impact on industry
  • Examining latest priorities and updates from the EMA
  • Activities necessary to support implementation and associated risks
09:45 - 10:20 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
INTERACTIVE ROUND TABLES: Sharing experiences with Russian GMP inspections
  • Alex Dranov - Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe, GmbH & Co. KG, Germany
more

In this interactive session, attendees will be broken into smaller groups to allow time for experience sharing in an informal environment.

  • How was the inspection organised?
  • What were the documentation requirements?
  • Sharing best practice for communicating with the authority during the GMP inspection
  • What were the pitfalls experienced and how were these overcome?
09:45 - 10:20 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Outlining the new regulation for variation in Brazil and sharing experiences with product registration
  • Lais da Silva - Senior Manager Regulatory Affairs, PharmaLex, Germany
more
  • Exploring the new regulation for variation
  • Specific requirements in Brazil
  • Practical experience – product registration
09:45 - 10:20 35 mins
Biosimilars
Understanding IP and patent protection considerations for biosimilars
  • Gemma Barrett - Senior Associate, Bristows LLP, UK
more
09:45 - 10:20 35 mins
IDMP Compliance
Exploring latest timelines of the EMA IDMP/SPOR roadmap and go-live for RMS and OMS
  • Andrew P Marr - Managing Director, Marr Consultancy Ltd., UK
more
  • Reviewing the latest status of RMS and OMS go-live and any first reactions from industry
  • Assessing key implications for industry and business processes of RMS and OMS go-live
  • Clarifying how the RMS and OMS systems work, how processes have been established and lessons learnt so far
  • Understanding how RMS and OMS will lay the foundations for PMS and SMS
10:20 - 10:55 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Understanding how drug interchangeability is defined and established according to amendments introduced by Federal Law No. 429-FZ
  • Anna Harrington Morozova - Scientific & Regulatory Director, Regem Consulting, UK
more
  • Reviewing how the amendments introduce and define drug interchangeability
  • Outlining how establishing a procedure for determining interchangeability will impact industry
  • Examining the criteria that must be covered in order for pharmaceuticals to be deemed interchangeable
  • Overcoming key challenges and pitfalls with the definition and establishment of interchangeability
10:20 - 10:55 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Brazil extended Q&A session
  • Carlos Thomazini - Regulatory Affairs & Quality Director, AbbVie Farmacêutica Ltda., Brazil
more

Attendees will be split into small groups for an interactive discussion allowing them to share experiences with product registration and solutions to common problems in Brazil with other attendees.  

10:20 - 10:55 35 mins
Biosimilars
Exploring the use and uptake of biosimilars across Europe
  • Richard Peck - Vice President / Regulatory Affairs, Lupin, Switzerland
more
  • Reviewing the uptake of biosimilars in different European countries
  • Determining where biosimilar uptake is particularly high and where it is particularly low
  • Outlining how regulatory requirements in different countries impacts biosimilar uptake
  • Understanding whether society in different countries view biosimilars in different ways, including different degrees of scepticism
10:20 - 10:55 35 mins
IDMP Compliance
The impact of IDMP on Regulatory Affairs / Operations, with special focus on eSubmission and RIM
  • Remco Munnik - Regulatory Information Director, Asphalion S.L., Spain
more
  • Exploring the impact of IDMP/SPOR on other key regulatory processes, such as eCTD, CESSP and eAF
  • Outlining how IDMP/SPOR overlaps with other current EMA projects, such as serialisation, falsified medicines, elabelling
  • Determining how the linking of IDMP/SPOR and other regulatory processes will impact industry
  • Overcoming key challenges expected with linking IDMP/SPOR and other regulatory initiatives
10:55 - 11:25 30 mins
Main agenda
Networking and Morning Coffee
11:25 - 12:00 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Normative Document writing and its importance for sales of product in Russia
  • Edelgard Rehak, Dr. Edelgard Rehak Consulting, Germany
more
  • Understanding the importance of Normative Document writing
  • Overcoming key challenges
11:25 - 12:00 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Clarifying the regulatory environment for registration in Mexico
  • Stefano Accorsi - Head of Regulatory Affairs “Rest of the World", Chiesi Farmaceutici S.p.A., Italy
more
  • Understanding the current regulatory environment and any recent or upcoming changes
  • Outlining the structure and activities of the New Molecule Committee (NMC) and any upcoming changes
  • Assessing the need to repeat tests in Mexico as part of import testing and whether any exemptions are made
  • Comparing regulatory requirements in Mexico to Europe
11:25 - 12:00 35 mins
IDMP Compliance
RIM and IDMP Synergies – like Fish & Chips….you shouldn’t think about one without the other
  • Sue Metz - Vice President, Technical, PAREXEL, USA
more
  • Outlining how both RIM and IDMP exist to support the Life Sciences Regulatory Process
    • The data may be a bit different, but essentially the processes are the same
  • Preparing for regulatory submissions being more and more Data-centric vs. Document-centric
  • Overview of the DIA RIM Working Group: a group of industry professionals working to identify common elements of RIM and define industry standards accordingly
12:00 - 12:35 35 mins
IDMP Compliance
Regulatory landscape: Opportunities and challenges with data in the global regulatory and pharmaceutical environment
  • Vada A Perkins - Founder and Managing Principal, IDENTIFICA, USA
more
  • Overview of the current regulatory landscape
  • Emerging/innovative technologies as it applies to regulatory science/technology and pharmaceutical sector
  • Challenges of adopting new emerging/innovative technology (e.g., digital transformation) within the regulatory framework
12:00 - 12:35 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Case study: Best practice for normative document preparation
  • Alessandra Leone - Global CMC Sr. Manager, Pfizer, Italy
more
  • Determining what needs to be included in the normative document, with considerations from Russian and Kazakh GMP Inspection experiences
  • Best practices for optimal normative document build – importance of communication with local affiliates
12:00 - 12:35 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Examining the regulatory framework and ensuring successful registration in Colombia
  • Ingrid Müller - Head Regulatory Affairs ROPU South America, Boehringer Ingelheim S.A., Argentina
more
  • Exploring the current regulatory environment and any recent or upcoming changes
  • Determining exactly what is required for MAA submissions, renewals and variations
  • Comparing regulatory requirements in Colombia to other LATAM countries and EU
12:00 - 12:35 35 mins
Biosimilars
Pricing and reimbursement considerations for biosimilars
  • Paul Craddy - Managing Director, Remap Consulting, Switzerland
more
  • Outlining how pricing and reimbursement considerations differ between different countries
  • Understand what is the payer viewpoint and approach to biosimilars
  • Exploring recent biosimilar pricing and market access success stories
  • Understanding the future outlook for biosimilar pricing and reimbursement over the next few years
12:35 - 13:10 35 mins
IDMP Compliance
Impact of IDMP on supply chain – approach for assessing CMO IDMP readiness and key lessons learned
  • Jens-Olaf Vanggaard - Director, Research & Development Practice, HighPoint Solutions, Switzerland
more

This session will focus on the role of Contract Manufacturing Organizations (CMOs) in achieving IDMP compliance. The session will cover:

  • Why your company should conduct an IMDP CMO Data Gap Assessment
  • Recommended approach for how to conduct an IDMP CMO Data Gap Assessment
  • Key Lessons Learned from other IDMP CMO Data Gap Assessments
12:35 - 13:10 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Understanding the regulatory landscape in Argentina, Chile, Peru, Costa Rica and Panama
  • Diana Guarin - Regulatory Affairs Director, AbbVie Inc., USA
more
  • Assessing the current regulatory framework and any upcoming changes
  • Overcoming the key challenges with submissions
  • Evaluating the classification and requirements for variations
  • Understanding the current status of harmonisation with the EU and whether there are any upcoming progressions
12:35 - 13:10 35 mins
Biosimilars
Project management for biosimilars
  • Anjan Selz - Vice President and Head of Biosimilars, Lupin, Switzerland
more
  • Some generic principles
  • Some biosimilar specific principles
  • The three defining moments for successful biosimilar development
12:35 - 13:10 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Bridging East and West: GxP Convergence within the CIS
  • Polina Dombure - Member of the Board, Inpharmatis, Latvia
more

In this session Polina Dombure, CEO of Inpharmatis reviews the challenges associated with operating GMP, RA and PV practices across the CIS countries. She discusses how convergence within the region has impacted the industry and examines likely expectations for the future.

13:10 - 14:30 80 mins
Main agenda
Networking Lunch
14:30 - 15:05 35 mins
IDMP Compliance
Latest updates and experiences with controlled vocabularies and data standards for successful IDMP implementation
  • Jens Martin - EU Business Lead Systems, F. Hoffmann-La Roche Ltd., Switzerland
more
  • Reviewing timelines related to the RMS go-live and when all controlled vocabularies will be in the system
  • Sharing any experiences with mapping between local controlled vocabularies and central SPOR data
  • Examining how EMA´s controlled vocabulary requirements impact a RIM solution
  • Outlining key challenges faced and advice on how these can be overcome
14:30 - 15:05 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Clinical trials of medicines in Ukraine: Current regulatory environment
  • Nataliia Bogdan, Independent Speaker (previously – Central Regulatory Authority), Ukraine
more
  • Clinical trials of medicines in Ukraine
  • Exploring the current regulatory environment
14:30 - 15:05 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Ensuring specific stability data requirements are met in Latin America
  • Prasanna Kumar Thenneti - Head, Regulatory Affairs – Emerging Markets, Dr. Reddy’s Laboratories, India
more
  • Outlining the specific dossier requirements for stability data in Latin America
  • Determining which types of studies must be initiated in order to register products in the region
  • Case examples of stability data requested and provided
  • Overcoming the key challenges associated with specific stability requirements
14:30 - 15:05 35 mins
Biosimilars
Assessing the regulatory expectations, opportunities and challenges for biosimilar orphan drugs
  • Rodeina Challand - General Manager, Challand Biosimilar Consulting, UK
more
  • Reviewing regulatory authority expectations for comparative clinical studies for biosimilar orphan drugs
  • Determining whether full-scale comparative clinical studies are always feasible
  • Overcoming challenges including limited populations and high costs of reference biopharmaceuticals
  • Outlining future opportunities and challenges for biosimilar orphan drugs on the market
15:05 - 15:40 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Practically conducting clinical trials in Russia and the impact of separating clinical trials from registration procedures under Federal Law No. 429-FZ
  • Anna Harrington Morozova - Scientific & Regulatory Director, Regem Consulting, UK
more
  • Understanding the Russian requirements in place for local clinical trials
  • Exploring success stories with conducting local clinical trials
  • Determining the impact of separating clinical trials from registration procedures on industry
  • Overcoming key challenges and pitfalls experienced with local clinical trials
15:05 - 15:40 35 mins
IDMP Compliance
Unifying Regulatory Information Management processes
  • Katrin Spaepen - Director of Strategy, Vault RIM, Veeva Systems, Belgium
  • Simon Taylor - Associate Solution Consultant, Veeva Systems, UK
more

This session will introduce you to the challenges and risks associated with approaching Regulatory Information and Submission Management as disparate processes. We will present a unified process model and unified applications that can significantly improve the processes, leading to greatly reduced compliance risks, improved business oversight and significantly improved value for your business. We will highlight the approach using a live demonstration.

15:05 - 15:40 35 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
Determining best strategies for filing a variation and gaining approval in Latin America
  • Silvia Nita - Global Regulatory Affairs CMC Manager, Roche, Switzerland
more
  • Outlining key requirements for filing variations in Latin America
  • Clarifying the classification of variations and whether this is harmonised across countries in Latin America
  • Exploring the timelines to get approval for variations
  • Overcoming the key challenges associated with filing variations in Latin America
15:05 - 15:10 5 mins
Biosimilars
End of the Biosimilars day Q&A session: A chance for any remaining questions from the day
15:40 - 16:10 30 mins
Main agenda
Networking and Afternoon Tea
16:10 - 16:45 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
Latest status updates of the Eurasian Economic Union (EEU) and implications for industry
  • Olesya Mertsalova - Regulatory Affairs Cluster Head, EEU, GSK, Russia
more
  • Outlining the current status and timelines for the EEU
  • Examining expectations for a common procedure of registration and dossier format
  • Determining how the EEU will work in practice
16:10 - 17:20 70 mins
Emerging Markets Stream 2: Latin America & Asia-Pacific
LATAM COLLABORATION ZONE
  • Carlos Thomazini - Regulatory Affairs & Quality Director, AbbVie Farmacêutica Ltda., Brazil
  • Stefano Accorsi - Head of Regulatory Affairs “Rest of the World", Chiesi Farmaceutici S.p.A., Italy
  • Ingrid Müller - Head Regulatory Affairs ROPU South America, Boehringer Ingelheim S.A., Argentina
  • Diana Guarin - Regulatory Affairs Director, AbbVie Inc., USA
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: Brazil

Round table 2: Mexico

Round table 3: Colombia

Round table 4: Argentina, Chile, Peru, Costa Rica and Panama

16:10 - 16:45 35 mins
IDMP Compliance
Reviewing the importance of close collaboration between different departments for effective IDMP implementation
  • Andrea Herrmann - Director, Strategy Implementation Leader, Merck KGaA, Germany
more
  • Clarifying which other departments will collaborate with regulatory for IDMP implementation
  • Understanding the benefit of close collaboration between regulatory and other departments
  • Outlining how IDMP can cause culture change including who holds ownership for different elements
  • Successfully transitioning to a centralised model and how this impacts different departments
16:45 - 17:20 35 mins
Emerging Markets Stream 1: Russia, CIS, Turkey, Middle East & Africa
INTERACTIVE ROUND TABLES: Preparing for changes with the new EEU procedures
  • Alex Dranov - Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe, GmbH & Co. KG, Germany
more

In this interactive session, attendees will be broken into smaller groups to allow time for experience sharing in an informal environment.

  • What is being done now to prepare for upcoming changes with the new EEU procedures?
  • What are the main concerns and what is most looked forward to about the EEU?
  • What have the main challenges been so far with preparing for new EEU procedures?
16:45 - 17:20 35 mins
IDMP Compliance
INTERACTIVE EXPERIENCE EXCHANGE: How are companies experiencing closer collaboration between different departments for successful IDMP implementation?
  • Andrea Herrmann - Director, Strategy Implementation Leader, Merck KGaA, Germany
more

In this interactive session, attendees will be split into small groups to share experiences and solutions to common problems in an informal environment.

17:20 - 17:25 5 mins
Main agenda
End of Conference Day One