Shanghai, China June, 28th

Seminar

2013

Introduction to Pharmaceutical Regulations and Standards EU and ICH

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Introduction to Pharmaceutical Regulations and Standards EU and ICH

Newlystar (Ningbo) Medtech Co. Ltd., China PharMillennium Consulting L.L.C., Montenegro Phagecon Servios e Consultoria Farmacutica, Lda., Portugal
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Speakers: - Ms. Shining Liu - Ms. Dragana Boberi Borojevi - Mr. Predrag Risti - Ms. Anabela Jesus Felicio
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Seminar Timetable
9:00 10:00 10:00 13:00

Registration of participants Opening session, Introduction of speakers Topics and lectures

EU treaties and legal system regulation, directives, guidelines Registration in EU regulatory bodies and procedures ICH and global impact on international harmonisation in pharmaceuticals EU CTD - assuring quality, safety and efficacy of medicines EU GMP - Contextualization, Implementation and Certification 13,00
13:30

13,30
16:30

Break
Workshop and Round Table Session

Questions and Answers

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PRESENTATION OF COMPANIES

-Ms. Shining Liu, Seminar Chair

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PRESENTATION OF COMPANIES

- Ms. Anabela Jesus Felicio

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Phagecon is a company dedicated to providing quality and excellence services to the pharmaceutical industry; industry Competitive and highly regulated atmosphere of the pharmaceutical sector makes the need and the opportunity; Founded in January 2006, Phagecon appears in this context of growing demand in the pharmaceutical sector, with the aim of offering a wide range of specialized services; services Currently Phagecon develops activities both nationally and internationally, strategically supporting several companies with their activities in the market for medicines and health products.

Team
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Team of highly qualified professionals with experience and proven knowledge that can offer excellent advice, scientific and regulatory support. Our skills: pharmaceutical sciences, chemistry, toxicology, medicine, microbiology, psychology, pharmacology and statistics. Network of and experts. consultants

Experienced professionals with skills in project management for the pharmaceutical sector.

Organization
9 MANAGEMENT

EXECUTIVE DIRECTOR

ACCOUNTING OFFICE

HUMAN RESOURCES

LEGAL OFFICE

OHS

ADMINISTRATIVE

CUSTOMER SERVICES

MARKETING INTRODUCTION

MARKETING MAINTENANCE

QUALITY

Services
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REGULATORY AFFAIRS (all types of health products) PHARMACOVIGILANCE PHARMACEUTICAL AFFAIRS (Quality Management, GMP, GDP) PROMOTIONAL MATERIALS / ADVERTISING ACTIVITIES (regulatory assessment and notification to Authorities) TECHNICAL TRANSLATIONS (Pharmaceutical , Medical , Scientific Accurate Multilingual Translations) ON-THE-CLIENT ALLOCATION AND TRAINING (at national and international companies)

Anabela Felcio
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EDUCATION / PROFESSIONAL QUALIFICATIONS

Anabela Jesus Felcio

E-mail: anabela.g.felicio@gmail.com Mobile: 00351 91 8216220

Merck Sigma Black Belt Certification, 2010 Lean Six Sigma Black Belt Certification, 2008 Lean Six Sigma Champion, 2007 Specialist in Pharmaceutical Industry, 2000 Auditor of Quality Management System, 1999 Specialist in Validation of Pharmaceuticals Processes, 1997

PROFESSIONAL EXPERIENCE

Degree in Pharmaceutical Sciences, 1987

Consultant & Pharmaceutical Auditor (Freelancer) - Consultant & Pharmaceutical Auditor, Lean Sensei, Six Sigma
Black Belt, Change Management, BCCM (Behaviour Coaching and Consequence Management)
(Since November 2012)

Merck Sharp & Dohme - Merck Sigma Leader; Production Manager; Project Manager
(Nov 2009 to Oct 2012)

Schering-Plough - Production Manager; RFT Champion; Project Manager

(Jun 2001 to Oct 2009)

OM Pharma - Quality Head; Project Manager; Production Manager

(Feb 1995 to May 2001)

Takeda Pharmaceutical - Project Manager; Head of Sterile Production; Quality Control & Quality Assurance Manager
(May 1987 to Jan 1995)

Career developed in national and international environments in the pharmaceutical industry, knowledge and major background in technical, human and business areas in Operations and Quality areas.

PRESENTATION OF COMPANIES

-Ms. Dragana Boberi Borojevi - Mr. Predrag Risti

Adobe Acrobat Document

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Seminar Targets
/ Essential knowledge regarding contemporary pharmaceutical regulations / Terms in Regulatory Affairs / Basic EU registration requirements and procedures / Format and content of EU CTD essential terms / Contemporary GMP requirements - EU and PIC/s
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Time to start....

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Shanghai, China June, 28th

Seminar

2013

Introduction to Pharmaceutical Regulations and Standards EU and ICH

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