5th Annual Biocides BPR Conference & Endocrine Disruptors Workshop

Daniela Romano - Eurofins Biolab
After her PhD in Biophysics and a Post Doc position in medical research, Daniela has been working with Eurofins, mainly on Biocides, since 2003. She was first in charge of stability studies and then the management of the Chemistry laboratory. She managed projects aiming towards Biocidal Products authorisation for several years and is now also involved in the risk assessment procedures. She has sound experience with a large variety of biocidal products.

Maristella Rubbiani - National Seconded Expert at EU COM - DG
Sante - Pesticides and Biocides Unit
Maristella is a member of the CA, BPC Committee and the national Committee for
authorization of biocides and PPPs. She is responsible of the national database for poison
centres according to Art 45 CLP and has more than 30 years of experience in regulatory
toxicology and C&L for risk assessment of substances and preparations. She has a degree in Biology and a PhD in Industrial and Environmental Hygiene.

Martina Duft - Senior Expert Regulatory Ecotoxicology knoell Germany GmbH
Dr Martina Duft is senior expert regulatory ecotoxicologist at knoell Germany GmbH. She
studied biology at the Ludwig Maximilian University Munich and is holding a PhD
in ecotoxicology from the JW Goethe University Frankfurt. After several years in ED related research, she has worked for >15 years in various regulatory sectors with a focus
on ecotoxicology and regulatory affairs. She is coordinator of the knoell ED expert team and key contact for the topic endocrine disruptors.

Mike Baldry - Independent Consultant, UK
Mike has worked for over 40 years on disinfectant development and regulation in various companies and has been involved with European biocides regulation since the earliest days of the BPD. He now works parttime as an independent regulatory consultant and continues his active involvement in biocides regulation and efficacy. He is Convenor of the CEN TC/216 Working Group 2, responsible for standards for assessing the efficacy of disinfectants used in the veterinary sector.

Darren Abrahams - Partner, Steptoe & Johnson LLP, Belgium 
Darren enables clients throughout the chemicals and life sciences supply chain to get and keep their products on the European Union market. He focuses on defense of products through strategic advice, advocacy before institutions and agencies, and litigation before EU and national courts and tribunals. He has a wealth of experience with the EU regulation of biocidal products, plant protection products (agrochemicals), REACH, classification, labelling and packaging, GM food and feed, cosmetics, and endocrine disruptors.

Michele Cavalleri - Eurofins Biolab, Chairman
GLP Facility Manager of the Biocidal Products Division in Eurofins Biolab (Italy). He has gained a solid expertise on efficay assessment of disinfectants. He is also member of the European Committee CEN TC 216 that establishes standardized methods of test and requirements for the antimicrobial efficacy of chemical disinfectants and antiseptics.

Francesca Fasano - Head of Business Unit Agro/Biocides, Chemsafe
Francesca has a sound expertise in chemistry with a Degree in Industrial Chemistry, one in Chemistry, and a PhD in Analytical Chemistry. During the PhD she worked at the US EPA in Athens (GA). Between 2008 and 2010 Francesca participated in several research
projects in analytical chemistry, with scholarships at the University of Turin, and at the Istituto Zooprofilattico of Turin. Since January 2011 she works at Chemsafe on Agro/biocide projects. In 2015 Francesca became Head of the Agro/biocide BU. In 2020 Francesca became head of the Chemical BU.

9:10 Welcome and introduction
Moderator, Daniela Romano, Regulatory Affair Manager for Biocidal Products, Eurofins Biolab

Session 1: Biocidal Product Family (BPF)
9:20 Risk assessment: Regulatory overview within BPF
To be confirmed soon

10:00 Outcome BPF working party
Industry expert to be confirmed soon

10:40 Consortia Formation and Cooperation for Biocidal Product Authorisation:
Different approaches
Francesca Fasano, Head of Business Unit Agro/Biocides, Chemsafe

11:20 - 11:50 Coffee break

11:50 Specific Case Study on a BPF
Daniela Romano, Eurofins Biolab Italy

12:20 Industry experience on a BPF: Company overview
Industry expert to be confirmed soon

12:50 - 14:00 Lunch Break

Session 2: Endocrine Disruptors

14:00 Implementation of the evaluation criteria for Endocrine Disruptors in the light of BPR Regulation 528/2012:
· The EU COM strategy for Endocrine Disruptors 
· Application of the guideline
· Impact on dossier evaluation
· Update on next steps and future perspective
Maristella Rubbiani, National Seconded Expert at EU COM - DG Sante - Pesticides and Biocides Unit

14:30 Practical aspects related to Endocrine Disruptors assessment
Martina Duft, Senior Expert Regulatory Ecotoxicology, knoell Germany GmbH

15:00 Session 3: Data Ownership Management
· Rights and Obligations Refresher
· Lessons from the BoA and ECHA
· Novel data scenarios
Darren Abrahams, Partner, Steptoe & Johnson LL

15:40 - 16:10 Coffee break

Session 4: Antimicrobial Efficacy

16:10 Efficacy Testing in the Veterinary Sector: 16:10 Efficacy Testing in the Veterinary
Sector:
· Disinfectant use in the veterinary sector (PT 3)
· Efficacy assessment and recent developments of CEN methods
· Developing an efficacy data package for a veterinary disinfectant product family
Mike Baldry, Independent Consultant, UK

16:40 Challenging efficacy assessments scenarios on:
· Laundry Disinfection (PT 2)
· Swimming Pool Disinfection (PT 2)
· Drinking Water Treatment (PT 5)
Michele Cavalleri, GLP Facility Manager - Eurofins Biolab Italy

17:10 - 17:30 Final Q&A

The official Conference language will be english.

We will organize in the relaxing area of Westin Palace at the end of the Conference,
on May 6th, a refreshment for speakers and delegates. Please confirm your presence
while submitting.

ENDOCRINE DISRUPTORS: FROM THEORY TO PRACTICE

ED properties of Biocidal Products have become a hot topic since 07 June 2018, because evaluating competent authorities assess the potential ED properties of all biocidal products.

The ECHA/EFSA guidance for the identification of endocrine disruptors, implies rising standards and challenging requirements for the assessment of all substances. The competent authorities will also take into consideration the ED properties of substances or products for procedures that are still under evaluation. This higly complex and rigorous
approach impacts all aspects associated to data requirements, testing and assessment
strategies.

Applicants should:
• Review the active substances in the light of the scientific ED criteria
• Be prepared to provide more information on the possible ED properties of active
substances in their application
• Consult the national authority responsible for the evaluation active substances before
testing
•This criteria will apply not only to active substances but also to co-formulants, which
are especially critical within ED assessment framework.

This Workshop aims to provide a fully understanding and in-depth insight into the new EU Endocrine Disruptor criteria, and the recent ECHA/EFSA Guidance. Key industry
experts will share valid and sound knowledge for identifying endocrine disrupting chemicals in the biocides area.

Agenda (9.30h - 13.00h)

9:30 Endocrine Disruptors - definition and criteria*

10:00 Main requirements of new EU ED Guidance*

10:30 Gathering and assembly of data*

11:00 Coffee break

11:15 Assembly of the lines of evidence, evaluation of completeness*

11:45 Regulatory consequences for applicants and implications on dossier preparation*
*Martina Duft
Senior Expert Regulatory Ecotoxicology, knoell Germany GmbH

12:15 Specific Case Study**
**Daniela Romano, Regulatory Affair Manager for Biocidal Products, Eurofins Biolab

12:45 - 13:00 Final Q&A

The official Workshop language is english.

Delegates can select a joint registration to attend both the Conference and the Workshop with a discount rate.
For more details on speakers and further assistance please contact us at:
FormazioneFarma@eurofins.com

Early bird price - Valid until March 31, 2020

• Conference and Workshop: 330€ + *VAT (if applicable)
• Conference attendance only (May 6, 2020): 260€ + *VAT (if applicable)
• Workshop attendance only (May 7, 2020): 120€ + *VAT (if applicable)

Note: Early bird price is valid for first and additional delegates attending from the same Conpany.

Full price - Valid after March 31, 2020

• Conference and Workshop:
  First delegate - 420€ + VAT (if applicable); Second delegate - 380€ + *VAT (if applicable)
• Conference attendance only (May 6, 2020):
  First delegate - 350€ + VAT (if applicable); Second delegate - 310€ + *VAT (if applicable)
• Workshop attendance only (May 7, 2020):
  First delegate - 150€ + VAT (if applicable); Second delegate - 130€ + *VAT (if applicable) -

Note - Conference day: Lunch included
Note - Workshop day: Lunch not included
*VAT applicable to italian companies only

General terms and conditions

The registration fee is payable in advance. Only after we have received your payment, you are entitled to attend the Conference and/or Workshop. A certificate of attendance for professional development will be given to each participant who completes the Conference and/or Workshop.
If you cannot attend the Conference/Workshop you have two options:
1. We are happy to welcome a substitute colleague at any time.
2. If you have to cancel entirely we must charge the following processing fees:
- until 1 week prior to the conference 50% of the registration fee will be charged;
- less than 1 week prior to the conference fullregistration fee will be charged.
Eurofins BioPharma Product Testing Italy reserves the right to cancel/alter the programme, the
speakers, the date or venue. If the event must be cancelled, registrants will be notified as soon as
possible and will receive a full refund of fees paid. Eurofins BioPharma Product Testing Italy is not
responsible for airfare, hotel or other costs incurred by registered delegates. Your data will be processed in accordance with EU regulation no. 679 of 27 April 2016 and Legislative Decree 30 June 2003, n. 196.

Eurofins BioPharma Product Testing Italy
Via Bruno Buozzi, 2
20090 - Vimodrone (MI)
Tel. + 39 0225071535
Fax +39 0225071599
e-mail: FormazioneFarma@eurofins.com