European Regulatory Affairs Strategy

Learning Objectives

23-24 April 2018Conference Hall “Depo”, Kiev

Suite 4, 8 Panasa Myrnoho Street, Kyiv,01011, Ukraine training@inpharmatis.com www.inpharmatis.com+380 44 569 01 06

Gain and consolidate the information required to stay current with European regulations

Implement and maintain procedures required to comply with current European regulatory laws

Attain the advanced information needed for the detection, assessment, understanding and prevention of adverse effects of medicines

Improve your maintenance and training systems

Correctly label products for sale within and outsidethe European UnionReduce the time taken for a product to go to market

Andrew Willis is a regulatory expert with 31 years of experience in pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.His experience is wide ranging, and will facilitate your under- standing of fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management. Andrew has a wealth of experience which he will share from his multiple roles he has been involved with in the pharmaceutical industry,

including:

Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus Orphan drug registrations of vaccine products and synthetic molecules NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission) Support for NBE during clinical phases and CMC support for a Biosimilar

Your Distinguished TrainerAndrew Willis

EUROPEAN REGULATORY AFFAIRS STRATEGY Two-day Training Course Agenda

DAY ONEIntroduction Review of current European and US regulatory legislation Managing new strategies based on the changes to European regulatory affairs Understanding the new regulatory procedures How to ensure compliance with Generics regulatory affairs How to ensure compliance with Paediatrics regulatory affairs

What’s new in regulatory affairs? Understanding the impact of new regulatory affairs for new products What is the impact for Generics? Interpretation of new guidelines What is the impact of new regulation on globalisation Developing a compliance strategy for the new regulatory affairs - Regulatory Procedures explained and Practical Exercise in choosing Procedures Management of all European procedures Understanding Regulatory Intelligence

Key Factors Influencing Strategy Procures Types Applications Types Outcomes Influencers

Review procedure for CTD and eCTD Review of CTD for global regulations

-Review writing patient/physician’s information-The importance of harmonisation-Summary of modules 3 to 5

The impact of eCTD on CTD An efficient transfer of regulatory information Review of the five modules Administrative information and prescribing information Common Technical Document summaries Quality systems / Sections

Practical Teams Allocated to discover QbD triangle—The way EU Regulators Think Non clinical study reports

DAY TWOPharmacovigilance Brief Update of Requirements in EU

Whats New Clinical Trial Regulations Falsified Medicines Medical Device Update

Labelling Regulations Labelling regulations Medical and pharmaceutical labelling Traceability US Regulations

Analysis of the Control and Management Required for Manu- facturing and Quality Control Testing of Current and New Products The principles and guidelines for GMP Harmonisation and co-ordination of GMP GMP implementation for dossier The role of regulatory agencies ICH Q7 Update Consequence of change to European and non-European regulations MRA

Advanced Product Lifecycle Management Compliance management Roll Out of Dossier Understanding EU Variations systems

Practical Exercise in Variations — Allocated Teams

Life-cycle management Strategic analyses of product life cycle management

Please note that the number of places is stricly limited

European RegulatoryAffairs Strategy Dates: 23-24 April, 2018Venue: Conference Hall “DEPO”, Kiev

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Suite 4, 8 Panasa Myrnoho Street, Kyiv,01011, Ukraine training@inpharmatis.com www.inpharmatis.com+380 44 569 01 06