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

6 Oct 2020, Online Training | Die Akademie Fresenius GmbH

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

Overview Programme Speakers Venue Prices & Services

Overview

How will this online training work?

This online training will be live – with interactive participation – and will be held in the English language. 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!

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

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

Programme

PLEASE NOTE: The indicated times refer to Central European Time CEST.

For further time zones, please view here

Tuesday, 6 October 2020

Course Leader
Rosalinda Gioia, Yordas Group, United Kingdom

8.45 CEST Welcome address by Akademie Fresenius and introduction by the Course Leader

9.00 CEST Introduction and Core principles of the EU Biocides 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

9.20 CEST Active substances approval process

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

9.40 CEST BPR Transitional Period

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

10.00 CEST Questions and Answers

10.10 CEST Coffee break

10.40 CEST 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?

11.00 CEST Treated Articles

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

11.20 CEST Summary of the morning session

11.30 CEST Activity 1

12.00 CEST Questions and Answers

12.10 CEST Lunch

13.10 CEST 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

13.30 CEST Product Authorisation Introduction and Criteria

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

13.50 CEST Product Authorisation Routes

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

14.10 CEST Activity 2

14.30 CEST Questions and Answers

14.40 CEST Coffee break

15.10 CEST 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

15.30 CEST Data Requirements for Product Authorisation

  • Data requirements for dossier preparation and product authorisation

15.50 CEST Introduction to IUCLID 6, R4BP 3 and the SPC Editor

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

16.10 CEST Summary of the afternoon sections

16.20 CEST Take home messages & last Questions

16.30 CEST End of the Training

Speakers

 

Name

Company

Rosalinda Gioia

Yordas Group (United Kingdom)

Rosalinda Gioia is an internationally recognised expert on ecotoxicology and is highly experienced in understanding chemical regulations. At Yordas Group Rosalinda project manages REACH Lead Registrations and Biocides active substance approval and product authorisation dossiers.

mehrweniger

Venue

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

Prices & Services

Participation Fee: € 495.00 plus VAT.

The registration fee includes the following benefits:

  • Participation in the Online Training
  • Training documentation (available after the training via download from our website)
  • Certificate of attendance

Group reductions

For joint bookings received from one company we grant a 15 % discount from the third participant onwards (it doesn’t apply for representatives of an authority or a public university).


Book now
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Anne Möller

Your Contact

Anne Möller
Programme and conceptual design

+49 231 75896-84
amoellerakademie-fresenius.de

Anne Möller

Your Contact

Anne Möller
Programme and conceptual design

+49 231 75896-84
amoellerakademie-fresenius.de

Anne Möller

Your Contact

Anne Möller
Programme and conceptual design

+49 231 75896-84
amoellerakademie-fresenius.de

Danielle Sörries

Your Contact

Danielle Sörries
Organisation and participant management

+49 231 75896-74
dsoerriesakademie-fresenius.de

Danielle Sörries

Your Contact

Danielle Sörries
Organisation and participant management

+49 231 75896-74
dsoerriesakademie-fresenius.de

Display / Supplement

Present your company at the event.

You can personally present your products and services directly to your specific target group. We would be happy to provide you with further information (without further obligation) on our range of available options – from displaying company information at the reception counter to including a supplement with information on your product portfolio in the event documentation package.

We would be pleased to assist you personally:

Semsigül Poschmann

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

Press contact

We offer journalists and editors a platform where they can get in touch with the experts.

If you are the editor of a specialist publication and interested in a press pass or media partnership, please contact us well in advance. We would be pleased to send you our press bulletin as well as photographic materials where available as soon as the event is over.

Please contact us:

Rebecca Keuters

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