00 Seminar Shanghai Intro Shining

8/13/2019 00 Seminar Shanghai Intro Shining

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20132013201320132013201320132013Seminar

Introduction to Pharmaceutical

Regulations and Standards EU and ICH

Shanghai, China

June, 28th


2/15


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



PRESENTATION OF COMPANIES

-Ms. Shining Liu, Seminar Chair




- 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

9

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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-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

00 Seminar Shanghai Intro Shining

Documents

Transcript of 00 Seminar Shanghai Intro Shining