3rd Risk & Lifecycle Management Summit on Pharma & Biopharma Operations

10-11th October | Ericeira | Portugal

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Come and participate in the best international yearly event on everything related to Risk & Lifecycle Management of Pharma & Biopharma Operations. Join the discussions with leading experts in the area as speakers, share best-practices and hear senior regulators discuss emerging regulatory trends.
EXHIBITORS OPPORTUNITY

Scientific Organizing Committee

Dr. Ajaz S. Hussain

President


National Institute for Pharmaceutical Technology and Education
USA

Dr. José C. Menezes

CEO


4TuneEngineering
Portugal

Dr. António Moreira

Vice-Provost


UMBC University of Maryland Baltimore County
USA

Speakers

Camilla Lindgren

Security of Supply Customer Support Specialist


GE Healthcare
Sweden

Dr. Anna Kwilas

Product CMC Reviewer


FDA/CBER
USA

Dr. Joey Studts

Director Late Stage Purification Development


Boehringer Ingelheim
Germany

Kurtis Epp

Senior Director, Plasma Product Development


CSL Behring AG
Switzerland

Dr. Morten Allesoe

Senior Consultant


NNE
Denmark

Dr. Pierre-Marie Eberst

Director - Head of Quality Management Systems


Merck Group KGaA
Switzerland

Dr. Lucy Cabral

Global Head of Supplier Quality and Product Validity


Roche-Genentech Group
USA

Sílvia Ribeiro

Senior QRM Specialist


4Tune Engineering
Portugal

Dr. Filipe Ataíde

Team Leader of Process Modelling and Engineering


Hovione
Portugal

Dr. Joerg Gampfer

Senior Fellow


Hovione
Portugal

Dr. Susan Rosencrance

Director, Office of Lifecycle Drug Products


FDA/CDER/OPQ
USA

Marta Germano

Associate Scientific Director, Analytical Development


J&J
Netherlands

Nuala Calnan

Founder and Principal


BioPharm Excel
Ireland
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Agenda Highlights

2 Days, 20 Talks & many discussions
  • Risk & Science-Based Approaches for Innovative Drug-product Development;
  • Patient-Centric Initiatives: Risk-Benefit Perspectives;
  • Risk Management beyond compliance;
  • New Pharmaceutical Quality Initiatives - FDA’s Structured Knowledge(KASA);
  • Business Processes, Operational Excellence & Patient satisfaction.
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Location

Vila Galé Ericeira Hotel
Largo dos Navegantes 1,
2659-501 Ericeira, Portugal
GPS: N38° 57' 37.29" - W9° 25' 03.58"
Phone: +351 217 907 610
Email: ericeira.reservas@vilagale.com | Subject: QRM Summit October 2019

Enjoy ERICEIRA, home of sun and surf.

Why Ericeira?
Ericeira is a surfing paradise located on the west Portuguese coast 30 min away from the capital, Lisbon. The town centre is a picturesque, touristic, fishing village, abounded of traditions and known as having a great variety of fish and seafood.
This village with an excellent geographic location, great climate and with uninhibited ocean views from most parts offers great surf spots which regularly break with world class perfect waves onto clean and classic sandy beaches like Ribeira de Ilhas, Coxos, Foz do Lizandro, São Julião, São Lourenço, Norte and São Sebastião.
It can provide great waves for both beginners and experienced surfers. Also, this surfing village has been visited by surfers from all over the world since the 70's, and recently became Europe's first World Surfing Reserve. first World Surfing Reserve.