New Seminars

New Seminars

SEMINARS’ TITLES

 

  1. SPOR DATA MANAGEMENT

DATE                                   – January 2023

SPEAKER                      – Very Experienced in Regulatory Affairs in Pharma Industry

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  1. PHARMACOVIGILANCE ADVANCED LEVEL

DATE                                    – 26 JANUARY 2023

SPEAKER    – B.Sc (Hons), PhD, MTOPRA, DIA, RQA, IOD, PIPA, MAPS Director

He has been involved with Pharmacovigiilance for the last 30 years and the last 25 years conducting audits globally in PV and GCP. He has attended over 100 inspections from a variety of Regulatory Authorities and conducted many training courses around the world on a variety of PV related subjects.

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  1. COMPUTER SYSTEMS VALIDATION (CSA)

DATE                            – February 15 & 16, 2023

 

SPEAKER    – He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, QRM and manufacturing process automation systems

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  1. DATA INTEGRITY INVESTIGATIONS

DATE                                    – February 8 & 9, 2023

SPEAKER    – Analytical chemist with over 30 years experience including 15 years working in the pharmaceutical industry. He has been a consultant for 18 years and trained auditor with 16 years experience. He has been involved with the validation of computerized systems for over 20 years.

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  1. VALIDATION OF ANALYTICAL PROCEDURES

DATE                                    – March 13

SPEAKER    – He studied biochemistry and has almost 30 years of experience in pharmaceutical analytics in drug development, global quality functions, head of industrial QC, head of QC Lifecycle management, and global reference standard coordinator at international pharmaceutical company.

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  1. CLEANROOM CONTAMINATION CONTROL BEST PRACTICES

DATE                      – March 15

SPEAKER               – Chemistry – Steriles Manufacturing Specialist for Big Pharma Industry all over the world. He sits on LBI/30, the British Committee for Cleanroom Technology.

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  1. SANCTIONS EXPERT COURSE

DATE                      –  February 15 & 16

SPEAKER               -Certified Sanction Specialist by ACSS. He has many years of experience in the Compliance department in banking organisations.

SEMINARS that have materialized

ORAL SOLID DOSAGE FORMS
March 15 & 16, 2022,  Speaker: PHARM. FATMA TAMAN
Online, Athens

 

PHARMACOVIGILANCE AUDIT PROCESS. AUDIT RISK ASSESSMENT REMOTE AUDIT DUE TO COVID -19 CAPA MANAGEMENT
July 15 & 16, 2022, Speaker: Dr GRAEME LADDS B.Sc (Hons); PhD, MTOPRA, DIA, RQA, IOD
Online, Athens

 

ADVANCED PHARMACOVIGILANCE REGULATORY SEMINAR
January 26, 2023, Speaker: Dr GRAEME LADDS
B.Sc (Hons), PhD, MTOPRA, DIA, RQA, IOD, PIPA, MAPS Director
Online

 

SIGNAL DETECTION AND REGULATORY EXPECTATIONS
May  10 & 11, 2021, Speaker: Dr GRAEME LADDS
B.Sc (Hons), PhD, MTOPRA, DIA, RQA, IOD, PIPA, MAPS Director
Online, Athens

 

THE NEW SIRE 2.0 SYSTEM – VETTING THE INSPECTION PROCESS
November 9 & 10, 2022, Speakers: Capt. Vikram Pratap Master Mariner, BSc Nautical Science, Certified Internal Auditor
Mr. Vinay Mathur, Chief Engineer, Certified Internal Auditor, Flag State Inspector.
Online, Athens

 

TABLETING GRANULATION
June 27 & 28, 2022, Speaker: Dr MİCHAEL GAMLEN, Founder and CSO at Gamlen Tableting LTD (since 2010-present)
Online, Athens

 

TECHNOLOGY TRANSFER
September 23 & 24, 2022, Speaker:  PHARM. FATMA TAMAN
Online, Athens

 

Validation of Analytical Procedures
March 1 & 2, 2022, Speaker: PAULİNE MCGREGOR PH.D. CCHEM MRSC
Online, Athens

 

ANNEX 16 CERTIFICATION BY A QP
BATCH RELEASE
October 14 & 16, 2022, Speaker: PHARM. FATMA TAMAN

 

BIOSIMILARS OVERVIEW AND STRATEGIES FOR SUCCESS
May 18 & 19, 2022, Speaker: AURELIO ARIAS
Engagement Manager, European Thought Leadership, IQVIA
Online, Athens

 

CLEANROOM CONTAMINATION CONTROL BEST PRACTICES
Marc 15, 2022, Speaker: TIM EATON B.Sc.
Chemistry, Steriles Manufacturing Specialist for AstraZeneca, UK.
Online, Athens

 

DIGITAL TECHNOLOGY IN REMOTE WORKING
June 17& 18, 2022, Speaker: HARA KAPSANAKI
Online, Athens

 

THE e-CTD EDITION 4 . AN OVERVIEW OF ITS MAIN OPPORTUNITIES, BENEFITS, MODULAR DATA STRUCTURE
AND TECHNICAL CONCEPTS
November 3, 2022, Speaker: MASSIMILIANO PALLADINO
Master Regulatory Affairs Degree and Chemistry, Organic Chemistry Degree at Università
degli Studi di Milano
Online, Athens

 

EU GMP FOR CANNABIS & CANNABIS PRODUCTS
GUIDELINES & IMPLICATIONS FOR CANNABIS & CANNABINOIDS RELATED PRODUCTS
February 25 & 26, 2022, Speaker: YINON COHAVY
Hemp & Cannabis Purification expert. Psilocybin & Psilocin extraction and purification
Online, Athens

 

VALIDATION OF FILTRATION PROSSES FOR PARENTERAL MEDICINAL PRODUCTS
March 30, 2022, Speaker: Michiel Rook, Global Concepts – Europe B.V.
Online Athens

 

GENOTONIC IMPURITIES FOCUS ON NITROZAMINES REGULATION – EVALUATION & TOXICOLOGICAL RISK ASSESSMENT
September 30, 2021, Speaker: CARLA LANDOLFI
European Registered Toxicology
Toxicology Consultant at ToxHub SrL
Rome – Italy
Online, Athens

 

CURRENT STATE OF GMP: DATA INTEGRITY AND DRAFT ANNEX 15 CHALLENGES
October 18, 2021, Speaker: IGOR GORSKY
Online, Athens

 

ICH Q2 (REVISION 2): VALIDATION OF ANALYTICAL PROCEDURES
March 12, 2022, Speaker: Dr. Joachim Ermer, Ermer Quality Consulting, Bensheim, Germany
Online, Athens

 

Lyophilization Process Practical Application in the Pharmaceutical Industry
December 3 & 6, 2021, Speaker: Georg Frinke
Online, Athens

 

MODULE 3 EFFECTIVE CMC WRITING & REVIEWS SKILLS
November 29 & 30, 2022, Speaker: RAJASHRI SURVASE OJHA & TEAM OF
PARTNERS
Online, Athens

 

NEW ANNEX I EUDRALEX VOL4 GMP EUROPE
March 29 & 30, 2021, Speaker: JF Duliere
Online, Athens

 

THE NEW COMPUTER SYSTEMS VALIDATION REQUIREMENTS (CSA)
February 15 & 16, 2022, Speaker: Chinmoy Roy, BSEE, MSCS, USFDA expert
Online, Athens

 

NITROZAMINES GMP. QUALITY RISK MANAGEMENT,
RISK ASSESSMENT METHODS, CASE STUDIES
April 21 & 22, 2021, Speaker: BRANKA PLJEVALJCIC
Online, Athens

 

THE CLINICAL TESTING IN THE COSMETIC FIELD FROM THEORY TO PRACTICE
June 24, 2021, Speaker: Dr VINCENZO NOBILE
R & D MANAGER – COMPLIFE GROUP (PAVIA, ITALY)
Online, Athens

 

“ MODERN DATA SYSTEMS” BEST PRACTICES & NEXT WAVE OF INNOVATION
June 29, 2017, Speaker: Stratos Idreos, Computer Science at Harvard University where he leads DASlab, the Data Systems Laboratory@Harvard SEAS.
Nicosia, Cyprus

 

VALIDATION OF FILTRATION PROSSES FOR PARENTERAL MEDICINAL PRODUCTS
March 30, 2020, Speaker: Michiel Rook, Global Concepts – Europe B.V.
Online, Athens

 

ADVANCED FINANCIAL MODELING Based on the FAST Modeling
March 7, 8, 10, 2017, Speaker: DIMITRIS LEIMONIS – Senior Key Corporate Accounts Manager at NBG Group
Online, Athens

 

“FRAUD AND CORRUPTION AUDITING” (Fraud and corruption detection, prevention and deterrence)
February 13,14,2017, Speaker: Mr. Konstantinos P. Triantafyllidis, CIA, CFSA, CCSA, CFE
BUCHAREST, ROMANIA

 

GDPR AND ITS SPECIFIC REQUIREMENTS
FOR PHARMACEUTICAL COMPANIES
January 31, 2020, Speaker:  Mrs.EVGENIA KOUVA PAPADIMITROPOULOU Lawyer  , with many years of legal experience , especially in the field of HEALTH AND MEDICINE.
BUCHAREST, ROMANIA

 

GOOD STORAGE & GOOD DISTRIBUTION PRACTISES (GSP-GDP)
OF MEDICINAL PRODUCTS
September 26, 2019, Speaker: Ms A. Georgiou, chemical engineer,
BUCHAREST, ROMANIA

 

INTERNATIONAL MARITIME LAW, MARINE INSURANCE UNDER
THE 1906 AND 2015 ACTS
July 14,15, 2021, Speakers:  PETER MELLETT,  Managing Director of BankServe Insurance Services &  SAIF ALMOBIDEEN Senior associate in the Global Maritime and International Trade team at
Stephenson Harwood LLP,
Online

 

Shipping Finance & Investment
Executive Course in collaboration with the lecturers
of “CASS BUSINESS SCHOOL” City, University of London
May 29,30, 2017, Speakers: Dr Nikos Nomikos Professor of Shipping Risk Management, Director MSc in Shipping, Trade & Finance
PhD (City), MSc (Distinction, City), BSc (AUEB) &   Dr Nikos C. Papapostolou, Senior Lecturer in Shipping Finance
PhD (City), MSc (City), BSc (Birmingham)
Athens

 

SHIPPING FINANCE RESTRUCTURING & TYPES OF LOANS
May 8, 9, 2021, Speaker:  JOHN LIAMIS  Financial Consultant at GMS Cash Buyers in Shipping Recycling.
Athens

 

SIGNAL DETECTION AND REGULATORY EXPECTATIONS
May 10, 11, 2021, Speaker: Dr GRAEME LADDS B.Sc (Hons); PhD, MTOPRA, DIA, RQA, IOD
Online, Athens

 

THE NEW BANKING REGULATORY LANDSCAPE IN EUROPE
February 27, 2017, Speaker: Dr. Faidon Kalfaoglou
Senior Economist at the Bank of Greece
Tirana, Albania

 

“VALUE ADDED MEDICINES”
“FIXED COMBINATION MEDICINES”
o Development – Categories
o Regulatory Procedures-New Guidelines
o New information at EU level
o Market Access
November 7, 2018, Speaker: Aikaterini Moraiti
Pharmacist Phd, Former Director National Organization
Greece f. CHMP, COMP,
BUCHAREST, ROMANIA

 

Developing a Fraud Audit Plan- Fraud Audit Report
February 7, 8, 2019, Speaker: THEOHARIS XATZIGRIGORIOU PhD(ca), CFE, CICA, CRMA
Nicosia, Cyprus

 

AUDITING THE TREASURY FUNCTION
September 27, 28, 2018, Speaker: PANAGIOTIS PAPADOPOULOS
B.A., M.A.Finance,
Nicosia, Cyprus