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For students

Information on Operation

Syllabus

CEMDC Standard Operating Procedure

e-Modules

e-Modules available for PharmaTrain Medicine Development Courses are listed at the PharmaTrain website under section e-Library. Please note that a separate password for opening the e-modules can be obtained through the PharmaTrain website. http://www.pharmatrain.eu/e-library/index.php

Examination Procedure

WP7 Good examination practices version 1.0

WP7 MCQs guidance

Download Lectures

Module 1

Module 1 Programme

Aranyi, Peter Lectures

  • Development candidate analysis. Case study: Bcr-Abl
  • Target analysis. Case study: selecting a target
  • Target identification and selection

Batori, Sandor Lectures

  • Lead optimisation and development candidate selection; testing for biological activity. 1.
  • Lead optimisation and development candidate selection; testing for biological activity. 2.

Ferdinandy, Péter Lecture

Gottwald, Matthias Lectures

  • Bayer and the DKFZ formed a long-term Strategic Alliance in Oncology in 2009
  • Pharmaceutical R&D – overview from a company perspective
  • Portfolio Management at Bayer Pharmaceuticals
  • The IMI project – IMI-PharmaTrain harmonized educational training

Harsing, Laszlo Lecture

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Kerpel-Fronius, Sandor Lectures

  • Innovative Medicine Initiative – PharmaTrain (IMI-PhT) harmonized educational program. The organization of the CEMDC
  • Medicine Development from viewpoint of the clinical investigator

Mikus, Endre Lectures

  • Principles of translational medicine: imaging, biomarker imaging, theranostics
  • Principles of translational medicine: relationship between animal and human pharmacology

Paal, Tamas Lecture

  • The European Regulatory Network. Benefit/risk evaluation of medicines during their life cycle

Tóthfalusi, László Lectures

  • Basic principles of pharmacokinetics
  • Pharmacokinetics: Take home message (Summary)
  • The importance of plasma level measurements in the non-clinical and clinical development of medicines

Stonier, Peter Lectures

Vajdai, Marta Lectures

  • Quality by design: A holistic concept of building quality in pharmaceuticals
  • A Fresh Look at Quality Assurance: Is Integrated Research Quality Assurance Possible?
  • Global integrated development of new medicines. Quality management

Whitty, Jeremy Lectures

Module 2

Module 2 Programme

Bass, Rolf Lectures

  • What is ICH?
  • Investigation Brochure
  • Non-Clinical Studies for clinical trials in peadiatric populations
  • Reproductive and Developmental toxicology for Clinical Trials

Cerne, Manica Lecture

  • Genotoxicity and carcinogenicity testing

Doljak, Bojan Lecture

  • Good laboratory practice

Grabnar, Iztok Lectures

  • Importance and practical applications of ADME, PK and TK in non-clinical studies
  • In vitro/in silico modelling of human kinetics

Horvat, Matej Lecture

  • Non-clinical and clinical aspects of biosimilar development

Kerpel-Fronius, Sándor Lectures

  • Dose finding and early clinical evaluation of medicines
  • Clinical development of high risk medicinal products

Mlinaric-Rascan, Irena Lectures

  • Biological medicinal products
  • Non-clinical Testing

Rozman Pungercar, Jerica Lecture

  • Introduction to biosimilar medicinal products

Silva Lima, Beatriz Lectures

  • Introduction to Case Studies for Estimation of starting dose in FTIH clinical trials
  • Problem Solving on Case studies for Esimating the starting dose in FTIH clinical trials
  • Nonclinical Evaluation of Biopharmaceuticals
  • Identifying and mitigating risks of investigational medicinal products for FIH clinical trials
  • Safety Pharmacology
  • Scheduling of general toxicological studies
  • 3Rs in vitro and human specific research: Where Does it Go?

Zvonar Pobirk, Alenka Lecture

  • Principles of dosage form design & paediatric formulations

Module 3

Module 3 Programme

Borvendég, János Lecture

  • Clinical Regulations

Cseh-Pálos, Andrea Lectures

  • Drug supply in clinical trials
  • Quality by Design

Kerpel-Fronius, Sándor Lectures

  • Ethics of drug research
  • The changing paradigm

Maciulaitis, Romaldas Lectures

  • Advanced Therapies
  • Difficulties and Failures
  • Early Clinical Development
  • Innovative Techniques

Niese, Detlef Lectures

  • Clinical protocol
  • Concept Sheet
  • Good Science Is Not Enough
  • The Choice of the Control Group
  • The Clinical Protocol
  • The Development Plan

Szakolczai-Sándor, Norbert Lecture

  • Clinical Data Collection

Tóthfalusi, László Lectures

  • Clinical Biostatistics I
  • Clinical Biostatistics II

Module 4

Module 4 Programme

Barótfi, Szabolcs Lecture

  • Using real-world evidence in pharmaceutical drug development

Fox, Anthony Lectures

  • Writing the statistical report
  • Excel introduction

Kerpel-Fronius, Sándor Lectures

  • Clinical trial protocol and trial report
  • EBM case
  • EBM case discussion
  • Clinical drug development in elderly patients
  • The types and the clinical significance of confirmatory and post marketing authorization clinical trials

Mazalin, Katalin Lectures

  • Types of data
  • Clinical study Conduct – Part I
  • Clinical study Conduct – Part II

Renczes, Gábor Lecture

  • Clinical Drug Development in Children

Tarnai, Judit Lecture

  • Quality Assurance in Clinical Trials

Module 5

Module 5 Programme

 Zuzana Bat’ová Lectures

  • Medicines regulation from the perspective of the Head of Medicines Agency
  • Off-label use / Unlicensed use
  • Summary of Product Characteristics (SmPC) / Patient Information Leaflets (PIL)

 Sándor Kerpel-Fronius Lecture

  • Clinical pharmacologic evaluation of adverse events. Evidence for association and causality AE and ADR

Jan Klimas Lecture

  • Short history of drug regulation
  • Short history of drug regulation
  • Background and general principles of human medicine regulation
  • Pharmacopoeias

Jana Klimasová Lectures

  • Overview of Regulatory Directives
  • Common Technical Document (CTD & eCTD). Overviews
  • Good Practices
  • Orphan drugs, paediatric data, advanced therapies, biosimilars, generics
  • Prescription-only vs. over-the-counter medicines
  • Alli product information
  • Xenical product information
  • Losec product information

Gábor Koncsik Lecture

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Jan Kyselovic Lecture

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Silvia Manduchová Lecture

  • Medical Device Regulation

Michaela Palágyi Lectures

  • Regulatory Affairs – 1
  • Regulatory Affairs – 2

Peter Potucek Lectures

  • The approval, appeals and referrals processes in Europe
  • Case study 3
  • Case study 4
  • Product withdrawal procedures

Ondrej Slanar Lecture

  • Regulatory Framework

Vid Stanulovic Lectures

  • Safety of Biologicals

 Dagmar Stara Lecture

  • Medicinal products  in the EU

Movie

Module 6

Module 6 Programme

József Bodrogi Lecture

  • A few aspects of the global and the internal healthcare

Aranka Bonyhádi Lecture

  • The practice of ethical pharmaceutical promotion

Dominique Dubois Lectures

  • Advanced Therapy Medicinal Products
  • Introduction to Pharmaco-Economics Principles
  • QALYs: The Holy Grail?

Balázs Hankó Lecture

  • New challenges for pharmacy and hospital drug market

Zoltán Kaló Lectures

  • Steps of economic evaluation – Selection of comparator
  • Steps of economic evaluation – Calculation of costs
  • Steps of economic evaluation – Decision rule & sensitivity analysis
  • Steps of economic evaluation – Measurement of health gain / Evidence synthesis
  • Introduction to economic modeling
  • Transferability of HTA between countries

Tamás Soroncz-Szabó Lecture

  • The hierarchy of evidence  / The long way from data to clinical practice

Tamás Szolyák Lecture

  • Pharmaceutical marketing

Module 7

 Module 7 Programme

Bátai, Árpád Lecture

Boyd, Alan Lectures

  • Gene Therapy, Vectors and their Regulation

Fodor, Eszter Lecture

  • Basic Principles os the Development of Medical Devices

Fodor, Krisztián Lectures

  • Various types of advanced therapies

Jankovics, István Lectures

  • Clinical Development of human vaccines
  • Case presentation of non-clinical and clinical development of vaccines

Kacskovics, Imre Lectures

  • Introduction to immunology: humoral and cellular immunity, adaptive immune response

Kerpel-Fronius, Sándor Lectures

  • IFAPP International Ethics Framework for Pharmaceutical Physicians (PPs) and Medicines Development Scientists (MDSs)
  • The clinical development of the combination of medicines and medical devices
  • Biological medicinal agents general characteristics, principles of production and clinical development
  • Biological medicinal products and advanced therapies

Kistner, Otfried Lecture

  • Immunological Background of Vaccines

Mathiász, Dóra Lecture

  • The Role Of Molecular Diagnostics (biomarkers) In The Treatment Decisions Of Tumor Therapy (primarily with mAbs)

Mészner, Zsófia Lecture

  • The clinical significance of immunizations

Mikus, Endre Lectures

  • Translational medicine, special issues to be addressed in the non-clinical development of biological medicinal agents

Pálos, Andrea Lecture

  • Clinical development of drug-device combinations

Telekes, András Lectures

  • Biological therapy of tumors with mAbs

Tóth, Zsuzsanna Lecture

  • Regulation of vaccines

Zelkó, Romána Lecture

  •  Biopharmaceutical formulation of biological medicinal agents

Module 8

 Module 8 Programme

Antal, István Lecture

  • The significance of biopharmaceutical formulation in the development of generic products

Aradi, Ildikó Lecture

  • Marketing authorization of biosimilar medicinal products.  Differences of the EMA and FDA regulations

Caroli, Sergio Lectures

  • Quality assurance and regulatory studies of follow-on medicinal products
  • The problems of counterfeiting and falsifying of medicinal products

Holló, Zsolt Lecture

Kaló, Zoltán Lecture

  • Health and economic aspects of pharmaceutical policies related to off-patent medicines

Kerpel-Fronius, Sándor Lectures

  • Clinical development of biosimilar medicinal agents

  • Clinical pharmacologic problems of reference pricing

  • Interchangeability of follow-on products

Klebovich, Imre Lecture

  • Generic medicinal products. Iopharmaceutical classification system (BCS). Comparative pharmacokinetic approach for the evaluation of bioequivalence

Mühlebach, Stefan Lectures

  • Non-Biological Complex MP: Definition, Characteristics

  • Nanomedicines. Definition, specific properties

  • Non-Biological Complex Drug Follow-on Versions (NBCD Similars)

Pálfi-Goóts, Herta Lecture

  • Marketing Authorisation of generic and added value generic medicinal products. EMA and FDA regulatory procedures

Soroncz-Szabó, Tamás Lecture

  • Information on follow-on drugs & the probable causes of their slow uptake

Stanulovic, Vid Lectures

  • Evaluation of immunogenicity. Case presentations
  • Safety of innovative and follow-on biological medicinal products

Szebeni, János Lecture

  • Immune side effects of liposomal medicinal agents and other nanomedicines

Szücs, Thomas Lectures

  • Reimbursement Strategies of Follow-on Medicinal Products
  • Role of Drug Expenditure in Healthcare Market and Healthcare Insurance

Thaler, György Lecture

  • Generic drug development

Tóthfalusi, László Lecture

  • Bioequivalence trials: design, evaluation, regulatory requirements

In Memoriam Professor Bühler