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

6 Oct 2020, Novotel Düsseldorf City West

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

Overview Programme Speakers Venue Prices & Services

Overview

You are asking yourself, whether you will be able to travel this autumn and whether to book this conference right now?

We all wish to go back to normal and as of June 2020 we have been able to implement on-site meetings, here in Germany. However, our social responsibility and the health of our customers, employees and speakers are of the utmost importance for us, which is why we closely monitor the developments and comply with the current recommendations of the authorities. That is why we guarantee that you can rebook all events booked with us at any time and free of charge - this way you maintain full flexibility with your planning! If the circumstances do not allow for an on-site meeting later this year, we will change this conference into a virtual meeting. We promise, that we will inform you about any developments in due course!

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 do you meet

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

Tuesday, 6 October 2020

Course Leader
Rosalinda Gioia, Yordas Group, United Kingdom

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

9.00 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 Active substances approval process

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

9.40 BPR Transitional Period

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

10.00 Questions and Answers
10.10 Coffee break

10.40 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 Treated Articles

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

11.20 Summary of the morning session

11.30 Activity 1

12.00 Questions and Answers
12.10 Lunch

13.10 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 Product Authorisation Introduction and Criteria

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

13.50 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 Activity 2

14.30 Questions and Answers
14.40 Coffee break

15.10 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 Data Requirements for Product Authorisation

  • Data requirements for dossier preparation and product authorisation

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

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

16.10 Summary of the afternoon sections

16.20 Take home messages & last Questions
16.30 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

Novotel Düsseldorf City West
Niederkasseler Lohweg 179
40547 Düsseldorf
Phone: +49 211 52060-0
E-Mail: h3279accor.com
http://www.novotel.com/de/hotel-3279-novotel-duesseldorf-city-west-seestern/index.shtml

We have reserved a limited number of rooms for our participants at reduced rates at the hotel. These rooms can be booked up to 4 weeks prior to the start of the event. Please book early and directly through the hotel quoting „Akademie Fresenius“ as reference.

Prices & Services

Participation Fee: € 495.00 plus VAT.

The registration fee includes the following benefits:

  • conference participation
  • conference documentation
  • lunch
  • coffee breaks and conference beverages

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).


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Event Documentation

Would you like to attend but cannot spare the time?

Although we cannot substitute an intensive exchange with your fellow colleagues, we can provide you with a complete set of event documentation. The event documentation package includes all the presentations on the event agenda (subject to the approval of our speakers). It will be sent out around two weeks after the event once we have received your payment (free of shipping costs). We will also provide you with details on how to access the restricted download section on our website. This section contains all the latest versions of the presentations in colour and in digital form.

Price: € 0.00 plus VAT


Order event documentation
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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