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Lead Registrant

 

Lead Registrant Webinar 1: Principi Generali sulla preparazione e trasmissione di un Dossier Lead Registrant Webinar 1: General principles of dossier preparation and submission

 

Presentazioni in italiano

Introduction - Kevin Pollard

Overview of Dossier Submission Part I - Roberta Bernasconi

Overview of Dossier Submission Part II - Javier Sanchez

Conclusions and Future Developments - Kevin Pollard

 

Lead Registrant Webinar 2: Requisiti di Informazione- parte I
Robust study summaries, weight of evidence approach and in vitro data

Lead Registrant Webinar 2: Information requirements - part I

 

Presentazioni in italiano

Introduction – Wim De Coen

Evaluation of Available Information – Wim De Coen

Weight of Evidence Approach – Jane Caley

How to Use In Vitro Data – Laura Rossi

 

Lead Registrant Webinar 3: Requisiti di Informazione- parte II
QSARs, waiving information requirements, read-across, categories and QSARs

Lead Registrant Webinar 3: Information requirements - part II

 

Presentazioni in italiano

Introduction – Wim De Coen

Waiving information requirements – Wim De Coen

QSARs – Doris Hirmann

Read across and categories – Tatiana Netzeva

 

Lead Registrant Webinar 4: Substance identity

Lead Registrant Webinar 4: Substance identity

 

Presentazioni

Introduction – Gabriele Christ

Key concepts and dossier preparation, Part I
Mono-constituent substances – Gabriele Christ (on behalf of Suvi Takala)

Key concepts and dossier preparation, Part II
Multi-constituent substances – Michał Skowron

Key concepts and dossier preparation, Part III
UVCB substances – Gabriele Christ

Conclusions – Michał Skowron

 

Lead Registrant Webinar 5: Technical completeness check (TCC tool)

Lead Registrant Webinar 5: Technical completeness check (TCC tool)

 

Presentazioni

Introduction – Mike Rasenberg

Overview of the Technical Completeness Check process – Javier Sanchez

Preparation of a registration dossier using IUCLID 5 – Benoit Dilhac

IUCLID 5 Training video: Installation and usage of the TCC plug-in – Benoit Dilhac

Conclusions – Mike Rasenberg

 

Lead Registrant Webinar 6: Chemical Safety Assessment (CSA) and CSR Part I

Lead Registrant Webinar 6: Chemical Safety Assessment (CSA) and CSR Part I

 

Presentazioni

Introduction to CSA – Wim De Coen    
Hazard assessment – George Fotakis                   
Use description and exposure scenario – Hélène Magaud

 

Lead Registrant Webinar 7: Chemical Safety Assessment (CSA) and CSR Part II

Lead Registrant Webinar 7: Chemical Safety Assessment (CSA) and CSR Part II

 

Presentazioni

Chesar - concept and overview – Andreas Ahrens
Assessment in Chesar – Hélène Magaud

Key messages – Hélène Magaud

 

Lead Registrant Webinar 8: Classification and labelling

Lead Registrant Webinar 8: Classification and labelling

 

Informazioni generali sul regolamento CLP – Gabriele Schöning

Questioni rilevanti per i Dichiaranti Capofila relative al CLP – Anja Klauk

Classificazione ed etichettatura nei fascicoli di registrazione – Terhi Kuljukka-Rabb

Conclusioni – Gabriele Schöning 

Lead Registrant Webinar 9: Business rules

Lead Registrant Webinar 9: Business rules

 

Introduction – Mike Rasenberg

Creating and joining the joint submission – Javier Sanchez

Preparing the dossier – Mike Rasenberg

Submitting the dossier – Javier Sanchez

Conclusions – Mike Rasenberg

 

Lead Registrant Webinar 10: Data sharing and Dissemination

Lead Registrant Webinar 10: Data sharing and Dissemination

 

Opening – Geert Dancet

Introduction to data sharing – Laurence Hoffstadt

Data sharing in SIEF – Laurence Hoffstadt

Data sharing disputes – Diana Antal

Dissemination – Catherine Cornu

Confidentiality claims – Javier Sanchez

Conclusions – Catherine Cornu

 

“Any translation present in this video recording result from a National competent authority of a webinar originally provided by the European Chemicals Agency in English. The scientific/technical wording has not been subject to review by the European Chemicals Agency. Please note that only the English version is the original version.”

 

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