Join this unique event! Come to the Medicines for Europe 17th Regulatory and Scientific Affairs Conference to get an update on recent regulatory developments.

Learn from the best and meet the best! – Take part in intense discussions on hot topics affecting the generic medicines industry with more than 200 participants including the competent authorities and well – known industry experts.

Meet the regulators – More than 60 representatives from the competent authorities attended our regulatory conference last year. Don’t miss this opportunity in 2018!

Top Agenda topics for 2018:

OPTIONAL 24 January 2018 – Pre-conference Workshops (separate registration)

• Pharmacovigilance – Regulatory interplay: Management of safety information; Signal management – embracing the changes; Risk Minimisation Measures; Communication in pharmacovigilance

• Telematics: Use of telematics tools to support business needs

25-26 January 2018 – Regulatory and Scientific Affairs Conference

• Availability of medicines – How to prevent and better mitigate shortages

• Watch this space in 2018!
o Regulatory consequences of Brexit
o Simplifying variations – update on regulatory optimisation
o Implementation phase of the EU/USA Mutual Recognition Agreement (MRA) – How to maximize the benefits
o New ICH quality guidelines under development: Q11 and Q12 – what is new and what impact can be expected?

• Falsified Medicines – what should the regulatory experts know about practical implementation?

• How can patients be provided with up to date and relevant information on their medicines?

• Regulatory challenges for repurposing established medicines

• From junior to senior regulatory affairs – How to shape the best regulatory team

SPECIAL SESSION: Put your questions to the Regulators. An opportunity to address questions to European Regulators

PRACTICAL WORKSHOP (Friday 26 January 2017 – 09.00 – 15.30): How to implement the Guideline on setting Health Based Exposure Limits (HBEL) – Following the EMA guideline on setting HBELs, which describes how companies can approach cleaning validation in a more scientific way, leading to a better understanding of cleaning processes and further reduction of risk for patients.

The interactive workshop will focus on:

• Calculation of HBELs
• Risk assessment and use of HBELs in cleaning validation
• Opportunities for Quality assurance and how to approach Inspections

In each session practical examples and case studies will be presented

To secure your place at this ‘must attend’ platform, please register NOW and you too can share information with leading experts and network with your peers.

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CONTACT

Lucia Romagnoli
M: +44 (0) 7 562 87 68 73

For more information on advertising, exhibition and sponsorship packages:
Trudy Beks
M: +31 6 4119 0824

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For any other media enquiries:
Andrea Bedorin
P: +32 (0)2 533 20 11