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20132013201320132013201320132013Seminar
Introduction to Pharmaceutical
Regulations and Standards EU and ICH
Shanghai, China
June, 28th
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Introduction to PharmaceuticalIntroduction to PharmaceuticalIntroduction to PharmaceuticalIntroduction to Pharmaceutical
Regulations and StandardsRegulations and StandardsRegulations and StandardsRegulations and Standards
EU and ICHEU and ICHEU and ICHEU and ICH
Newlystar (Ningbo) Medtech Co. Ltd., ChinaPharMillennium Consulting L.L.C., Montenegro
Phagecon Servios e Consultoria Farmacutica, Lda.,Portugal
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Speakers:
- Ms. Shining Liu
- Ms. DraganaBoberi Borojevi
- Mr. Predrag Risti
- Ms. Anabela JesusFelicio
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Seminar Timetable
ICH and global impact on international harmonisation in pharmaceuticals
Registration in EU regulatory bodies and procedures
Questions and Answers
Workshop and Round Table Session16:3013:30
Break13,13,13,13,3000011113,,,,00000
EU GMP - Contextualization, Implementation and Certification
EU CTD - assuring quality, safety and efficacy of medicines
EU treaties and legal system regulation, directives, guidelines
Topics and lectures13:0010:00
Registration of participantsOpening session, Introduction of speakers
10:009:00
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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 industrypharmaceutical industry;
Competitive and highly regulated atmosphereregulated 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 servicesspecialized services;
Currently Phagecon develops activities both nationally andnationally and
internationally,internationally, strategically supporting several companies with their
activities in the market for medicines and health products.
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Team
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Team of highly qualified professionalshighly qualified professionals with experience and proven
knowledge that can offer excellent advice, scientific and regulatorysupport.
Our skills: pharmaceutical sciences, chemistry, toxicology, medicine,
microbiology, psychology, pharmacology and statistics.
Network of consultants
and experts.
Experienced professionals
with skills in project
management for the
pharmaceutical sector.
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Organization
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MANAGEMENT
ADMINISTRATIVE CUSTOMERSERVICES
MARKETINGINTRODUCTION
MARKETINGMAINTENANCE
QUALITYQUALITY
ACCOUNTINGOFFICE
EXECUTIVE DIRECTOR
LEGAL OFFICE
HUMANRESOURCES
OHS
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Services
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REGULATORY AFFAIRS
(all types of health products)
ON-THE-CLIENT ALLOCATION AND TRAINING
(at national and international companies)
PHARMACOVIGILANCE
PROMOTIONAL MATERIALS /
ADVERTISING ACTIVITIES
(regulatory assessment and notification to
Authorities)
PHARMACEUTICAL AFFAIRS
(Quality Management, GMP, GDP)
TECHNICAL TRANSLATIONS
(Pharmaceutical , Medical , Scientific Accurate Multilingual Translations)
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Anabela Felcio
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Anabela Jesus Felcio
E-mail:[email protected]: 00351 91 8216220
EDUCATION / PROFESSIONAL QUALIFICATIONS
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
Degree in Pharmaceutical Sciences, 1987PROFESSIONAL EXPERIENCE
Consultant & Pharmaceutical Auditor(Freelancer) - Consultant & Pharmaceutical Auditor, Lean Sensei, Six SigmaBlack 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 majorbackground in technical, human and business areas in Operations and Quality areas.
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PRESENTATION OF COMPANIES
-Ms. Dragana Boberi Borojevi
- Mr. Predrag RistiAdobe Acrobat
Document
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Seminar Targets
Essential knowledge regardingcontemporary pharmaceutical regulations
Terms in Regulatory Affairs
Basic EU registration requirements and
proceduresFormat and content of EU CTD essential
terms
Contemporary GMP requirements - EU andPIC/s
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Time to start....
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20132013201320132013201320132013Seminar
Introduction to Pharmaceutical
Regulations and Standards EU and ICH
Shanghai, China
June, 28th