Akademie Fresenius Intensive Training "Approval Process and Core Principles of the BPR" +++ONLINE TRAINING+++

24.03. - 25.03.2021, Online Training | Die Akademie Fresenius GmbH

Akademie Fresenius Intensive Training "Approval Process and Core Principles of the BPR" +++ONLINE TRAINING+++

Übersicht Programm Veranstaltungsort Preise & Leistungen

Übersicht

This training is aiming to give you the basic knowledge on how to register biocides in the EU. In a compact format on 2 consecutive mornings, you will be familiarised with the core principles of the BPR. If you are relatively new to the industry, or you have recently returned to your job after a leave and want to refresh your basic knowledge, this is just the perfect opportunity for you. It is also an offer to those, working in the wider chemical industry, whose companies have recently made their debut in the Biocides world by bringing a disinfectant to market, using a Covid-related derogations and would now like to develop and extend this area.

Learning Outcomes

  • Explain how your products fall withing the scope of the biocide legislation in Europe
  • Outline your obligations to become compliant
  • Understand the options available for biocidal product authorisation in the EU
  • Understand the steps leading to a successful product application submission

This course will cover

  • Core principles of the EU BPR Regulation
  • Active substances approval process
  • Treated Articles
  • BPR Transitional period
  • Article 95
  • Product Authorisation Introduction and Criteria
  • Product Authorisation Routes
  • Core principles of Product families
  • Data Requirements
  • Practical exercises

How will this online training work?

This online training will be live – with interactive participation – and will be held in English. Prior to the training, we will provide you with your login details which will allow you to participate and ask questions from your preferred location. All you need is a stable internet connection and an audio hardware system – and away you go!

Who will benefit from this training?

Professionals working in the fields of:

  • Registration, regulatory affairs
  • Preparing and submitting product authorisations
  • EU manufacturers of biocidal products and treated articles
  • EU importers of biocidal products and treated articles

Sectors that should take part:

  • Biocidal Industries
  • Professional Associations
  • Consultancies

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Picture credit: Fotolia/adobestock.com © NDABCREATIVITY

Programm

PLEASE NOTE: The indicated times refer to Central European Time CET.
For further time zones, please view here.

Wednesday, 24 March 2021

Course Leader
Rosalinda Gioia
, Yordas Group, United Kingdom

9:15 CET - Welcome address by Akademie Fresenius and introduction by Rosalinda Gioia

9:30 CET - Introduction and Core principles of the EU Biocidal Product Regulation (EU BPR)

  • Overview on the basic principles and terminology of the Biocides legislation
  • Introduction to the new concepts and definitions of the regulation

9:50 CET - Active substances approval process

  • Overview of the evaluation and approval process of active substances used in biocidal product(s)

10:10 CET - BPR Transitional Period

  • The transitional provisions of the BPR explained
  • Implications for companies placing their biocidal product(s) on the market


10:30 CET - Questions and Answers
10:40 CET - Coffee break

11:00 CET - Article 95

  • Article 95 of the EU BPR
  • Remarks on how it ensures a fair sharing of costs of generating data and supporting actives substances
  • How to ensure compliance with article 95?

11:20 CET - Treated Articles

  • Definition of ´treated article`
  • Regulatory obligations to meet for ´treated articles` under the EU BPR

11:40 CET - Summary of the morning session

11:50 CET - Activity 1

12:20 CET - Questions and Answers
12:40 CET - End of the first day

Thursday, 25 March 2021

Course Leader
Rosalinda Gioi
a, Yordas Group, United Kingdom

9:20 CET - Welcome address by Akademie Fresenius and introduction by Rosalinda Gioia

9:30 CET - Borderline Products

  • The thin border between different types of products
  • The product definition as prerequisite for the respective regulatory requirements
  • Examples of the criteria, that are decisive for a classification
  • How the enable the applicant to understand which regulatory framework is relevant for compliance

9:50 CET - Product Authorisation Introduction and Criteria

  • Introduction on the criteria that must be met to get biocidal product(s) authorised in the EU

10:10 CET Product Authorisation Routes

  • Discussion of the different routes of product authorisation
  • How decide which type will be the most suitable and cost-effective?

10:30 CET - Activity 2

10:50 CET Questions and Answers
11:00 CET Coffee break

11:20 CET Core principles of Product Families

  • Overview of Product Families under EU BPR
  • Definition
  • What principles and approaches must be followed to group products into families

11:40 CET - Data Requirements for Product Authorisation

  • Data requirements for dossier preparation and product authorisation

12:00 CET - Introduction to IUCLID 6, R4BP 3 and the SPC Editor

  • Introduction to the necessary IT Tools for preparing and submitting your application

12:20 CET - Summary of the afternoon sections

12:30 CET - Take home messages & last Questions
12:50 CET - End of the training



Veranstaltungsort

Online Training | Die Akademie Fresenius GmbH
This training is going to be held online.
Your Hotline for technical questions:
Telefon: +49 231 75896-50
E-Mail: infoakademie-fresenius.de
www.akademie-fresenius.de

Preise & Leistungen

Teilnahmepreis: € 595,00 zzgl. MwSt.

Im Teilnahmepreis sind folgende Leistungen enthalten:

  • Teilnahme an dem Online-Training
  • Veranstaltungsdokumentation (zum Download nach dem Training)
  • Teilnahmezertifikat

Gruppenrabatt

Bei gemeinsamer Anmeldung aus einem Unternehmen erhalten der dritte und jeder weitere Teilnehmer 15 % Rabatt (gilt nicht für Vertreter einer Behörde oder öffentlichen Hochschule).


Jetzt anmelden
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Anne Möller

Ihre Ansprechpartnerin

Anne Möller
Inhalt und Konzeption

+49 231 75896-84
amoellerakademie-fresenius.de

Anne Möller

Ihre Ansprechpartnerin

Anne Möller
Inhalt und Konzeption

+49 231 75896-84
amoellerakademie-fresenius.de

Danielle Sörries

Ihre Ansprechpartnerin

Danielle Sörries
Organisation und Teilnehmermanagement

+49 231 75896-74
dsoerriesakademie-fresenius.de

Danielle Sörries

Ihre Ansprechpartnerin

Danielle Sörries
Organisation und Teilnehmermanagement

+49 231 75896-74
dsoerriesakademie-fresenius.de

Auslage / Beiheftung

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Gerne beraten wir Sie persönlich:

Semsigül Poschmann

Semsigül Poschmann
Telefon: +49 231 75896-94
sposchmannakademie-fresenius.de

Pressekontakt

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Wenn Sie als Redakteur der Fachpresse Interesse an einem Pressepass oder einer Medienpartnerschaft haben, kontaktieren Sie uns bitte frühzeitig. Gerne senden wir Ihnen im Anschluss an die Veranstaltung die Pressemitteilung und – sofern vorhanden – Fotomaterial zu.


Sprechen Sie uns an:

Rebecca Keuters

Rebecca Keuters
Telefon: +49 231 75896-76
rkeutersakademie-fresenius.de