Michele Cavalleri , Eurofins Biolab

Maristella Rubbiani , EU COM - DG Sante

Daniela Romano , Eurofins Biolab

Mike Baldry, Independent Consultant , UK

Darren Abrahams , Steptoe & Johnson LLP

Martina Duft , knoell Germany

Francesca Fasano , Chemsafe

Other industry experts to be confirmed soon

5TH ANNUAL BIOCIDES

CONFERENCE 2020

conference - may 6, 2020

INSIGHTS ON BPR hot topics

Biocidal product family

Data  ownership

Antimicrobial efficacy

Selected speakers

the WESTIN PALACE HOTEL

MILAN - ITALY

Endocrine Disruptors

workshop - May 7, 2020

Endocrine disruptors:

From theory to practice

Session 1: Biocidal Product Family (BPF) 9:20 Risk assessment: Regulatory overviewwithin BPFTo be confirmed soon 10:00 Outcome BPF working partyIndustry expert to be confirmed soon 10:40 Consortia  Formation and Cooperationfor  Biocidal Product  Authorisation: DifferentapproachesFrancesca Fasano, Head of Business UnitAgro/Biocides, Chemsafe 11:20 - 11:50 Coffee break 11:50 Specific Case Study on a BPFDaniela Romano, Eurofins Biolab Italy 12:20 Industry experience on a BPF: Company overviewIndustry expert to be confirmed soon 12:50 - 14:00 Lunch Break

Session 2: Endocrine Disruptors

The new EU ED Guidance – requirements,challenges and first experiences     ED assessment of actives and biocidalproducts, co-formulant screeningapproach       Practical implications, regulatoryconsequences and recommendations

14:30 Practical aspects related toEndocrine Disruptors assessment:       

Martina DuftSenior Expert Regulatory Ecotoxicology,knoell Germany GmbH

THE OFFICIAL CONFERENCE LANGUAGEWILL BE ENGLISH

The EU COM strategy for EndocrineDisruptorsApplication of the guidelineImpact on dossier evaluationUpdate on next steps and futureperspective

14:00 Implementation of the evaluationcriteria for Endocrine Disruptors in the lightof BPR Regulation 528/2012:

Maristella Rubbiani, EU COM - DG SantePesticides and Biocides Unit

15:00 Session 3: Data OwnershipManagement

Session 4: Antimicrobial Efficacy

Disinfectant use in the veterinary sector(PT 3)Efficacy assessment and recentdevelopments of CEN methodsDeveloping an efficacy data package fora veterinary disinfectant product family

16:10 Efficacy Testing in the VeterinarySector:

Mike Baldry, Independent Consultant, UK

Laundry Disinfection (PT 2)Swimming Pool Disinfection (PT 2)Drinking Water Treatment (PT 5)

16:40 Challenging efficacy assessmentsscenarios on:

Michele Cavalleri, GLP FacilityManager - Eurofins Biolab Italy 17:10 - 17:30 Final Q&A Note: Times/topics might be subject to change We will organize in the relaxing area of theWestin Palace at the end of the Conference,on May 6th, a refreshment for speakers anddelegates. Please confirm your presencewhile submitting.

Rights and Obligations Refresher Lessons from the BoA and ECHA Novel data scenarios

Darren AbrahamsPartner, Steptoe & Johnson LL 15:40 - 16:10 Coffee break

MAY 06, 2020 - CONFERENCE - FULL DAY

AGENDA

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

ANNUAL BIOCIDES CONFERENCE 2020

9:30 Endocrine Disruptors - definition andcriteria* 10:00 Main requirements of new EU EDGuidance* 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 applicantsand implications on dossier preparation**Martina DuftSenior Expert Regulatory Ecotoxicology, knoell Germany GmbH 12:15 Specific Case Study****Daniela Romano, Regulatory Affair Managerfor Biocidal Products, Eurofins Biolab 12:45 - 13:00 Final Q&A ì.

MAY 07, 2020 - HALF DAY

P O S T C O N F E R E N C E W O R K S H O P

ENDOCRINE DISRUPTORS: FROM THEORY TO PRACTICE

Delegates can select a joint registration toattend both the Conference and theWorkshop with a discount rate. For more details on speakers and furtherassistance please contact us at:FormazioneFarma@eurofins.com Full Conference and Workshop details:https://www.eurofins.it/formazione/conferenze-e-workshop/

Agenda (9.30h - 13.00h)

THE OFFICIAL WORKSHOP LANGUAGEWILL BE ENGLISH

ANNUAL BIOCIDESCONFERENCE 2020

ED properties of Biocidal Products havebecome a hot topic since 07 June 2018,because evaluating competent authoritiesassess the potential ED properties of allbiocidal products. The ECHA/EFSA guidance for theidentification of endocrine disruptors, impliesrising standards and challenging requirementsfor  the assessment of all substances. Thecompetent authorities will also take intoconsideration the ED properties of substancesand products for procedures that are stillunder evaluation. This higly complex andrigorous approach  impacts all aspectsassociated to data requirements, testing andassessment strategies. Applicants should:• Review the active substances in the light of the scientific ED criteria and the new EU ED Guidance• 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 of active substances before testing These criteria will apply not only to activesubstances but also to co-formulants, whichare especially critical within ED assessmentframework. This workshop aims to provide a fullunderstanding and in-depth insight into thenew EU Endocrine Disruptor criteria, and therecent ECHA/EFSA ED Guidance. Key industryexperts will share valid and sound knowledgefor identifying endocrine disrupting chemicalsin the biocides area.

Introduction

Daniela Romano, Regulatory Affair Manager forBiocidal Products, Eurofins Biolab ItalyAfter her PhD in Biophysics and a Post Docposition in medical research, Daniela has beenworking with Eurofins, mainly on Biocides,since 2003. She was first in charge of stabilitystudies and then the management of theChemistry laboratory. She managed projectsaiming towards Biocidal Products authorisationfor several years and is now also involved inthe risk assessment procedures. She has soundexperience with a large variety of biocidalproducts. Maristella RubbianiNational Seconded Expert at EU COM - DGSante Pesticides and Biocides UnitMaristella is a member of the CA, BPCCommittee and the national Committee forauthorization of biocides and PPPs. She isresponsible of the national database for poisoncentres according to Art 45 CLP and has morethan 30 years of experience in regulatorytoxicology and C&L for risk assessment ofsubstances and preparations.She has a degree in Biology and a PhD inIndustrial and Environmental Hygiene. Martina DuftSenior Expert Regulatory Ecotoxicologyknoell Germany GmbHDr Martina Duft is senior expert regulatoryecotoxicologist at knoell Germany GmbH.  Shestudied biology at the Ludwig MaximilianUniversity Munich and is holding a PhDin ecotoxicology from the JW Goethe UniversityFrankfurt. After several years in ED relatedresearch, she has worked for >15 years invarious regulatory sectors with a focuson  ecotoxicology and regulatory affairs. She iscoordinator of the knoell ED expert team andkey contact for the topic endocrine disruptors. Michele Cavalleri, GLP Facility ManagerEurofins Biolab ItalyHe has gained a solid expertise on efficayassessment of disinfectants. He is alsomember of the European Committee CEN TC216 that establishes standardized methods oftest and requirements for the antimicrobialefficacy of chemical disinfectants andantiseptics.

Mike BaldryIndependent Consultant, UKMike has worked for over 40 years ondisinfectant development and regulation invarious companies and has been involvedwith European biocides regulation since theearliest days of the BPD. He now works part-time as an independent regulatoryconsultant and continues his activeinvolvement in biocides regulation andefficacy. He is Convenor of the CEN TC/216Working Group 2, responsible for standardsfor assessing the efficacy of disinfectantsused in the veterinary sector. Francesca FasanoHead of Business Unit Agro/Biocides,ChemsafeFrancesca has a sound expertise inchemistry with a Degree in IndustrialChemistry, one in Chemistry, and a PhD inAnalytical Chemistry. During the PhD sheworked at the US EPA in Athens (GA).Between 2008 and 2010 Francescaparticipated in several research projects inanalytical chemistry, with scholarships atthe University of Turin, and at the IstitutoZooprofilattico of Turin. Since January 2011she works at Chemsafe on Agro/biocideprojects. In 2015 Francesca became Head ofthe Agro/biocide BU. In 2020 Francescabecame head of the Chemical BU. Darren AbrahamsPartner, Steptoe & Johnson LLP, BelgiumDarren enables clients throughout thechemicals and life sciences supply chain toget and keep their products on the EuropeanUnion market. He focuses on defense ofproducts through strategic advice, advocacybefore institutions and agencies, andlitigation before EU and national courts andtribunals. He has a wealth of experiencewith the EU regulation of biocidal products,plant protection products (agrochemicals),REACH, classification, labelling andpackaging, GM food and feed, cosmetics,and endocrine disruptors. Other industry experts to be confirmed soon.

TOP SPEAKERS

ANNUAL BIOCIDESCONFERENCE 2020

Title, First name, Second name:___________________________________________________Company:___________________________________________________Department:___________________________________________________Company address:___________________________________________________Bill-to-address (if different):___________________________________________________Phone/Mobile number:___________________________________________________E-mail: ___________________________________________________ Important: Indicate your company's VAT ID number: ___________________________________________________ I will attend post-Conference refreshment on May 6th,2020: YES NO Date: Signature:_______________ ________________________________ Email this form to: FormazioneFarma@eurofins.com

EARLY BIRD PRICE VALID UNTIL MARCH 31ST, 2020

FULL PRICE VALID AFTER MARCH 31ST, 2020

VENUE AND TIMING

BANK DETAILS

REGISTRATION FORM

ORGANIZATION AND CONTACTS

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

The Westin Palace, MilanPiazza della Repubblica, 20, 20124 Milan https://www.marriott.com/hotels/travel/milwi-the-westin-palace-milan/ Conference: May 6th, 202009:10h - 17:30hRegistration of delegates: 08:45h-09:10h Post Conference refreshment: 17:45h Workshop: May 7th, 202009:30h - 13:00hRegistration of delegates: 09:00h-09:30h

UNICREDIT SPAABI: 2008 CAB: 20600 CIN: NC/C: 000004846325IBAN: IT04 N020 0820 6000 0000 4846 325VAT ID: 00762140960

Conference and Workshop:420€ + VAT (if applicable) - First delegate380€ + VAT (if applicable) - Second delegate Conference attendance only (May 6th, 2020):*350€ + VAT (if applicable) - First delegate*310€ + VAT (if applicable) - Second delegate Workshop attendance only (May 7th, 2020):**150€ + VAT (if applicable) - First delegate**130€ + VAT (if applicable) - Second delegate *Conference day lunch included **Workshop day lunch not included PAYMENT OPTION VALID: BANK TRANSFER

Eurofins BioPharma Product Testing ItalyVia Bruno Buozzi, 220090 - Vimodrone (MI)Tel. + 39 0225071535e-mail: FormazioneFarma@eurofins.comhttps://www.eurofins.it/formazione/conferenze-e-workshop/

Terms and ConditionsThe organizer will confirm your participation afterreceiving the signed registration form.The organizer requires the full payment of theregistration fee in advance through bank transfer.Only after we have received your payment, you areentitled to attend the Conference and/or Workshop.If you cannot attend the Conference or Workshopyou have two options:1. We are happy to welcome a substitute colleagueat any time.2. If you have to cancel entirely we must charge thefollowing processing fees:- until 1 week prior to the event 50% of theregistration fee will be charged;- less than 1 week prior to the conference fullregistration fee will be charged.Registration fee includes participation,refreshments, lunch (if available) anddocumentation package.Eurofins BioPharma Product Testing Italy reservesthe right to cancel/alter the programme, thespeakers, the date or venue. If the event must becancelled, registrants will be notified as soon aspossible and will receive a full refund of fees paid.Eurofins BioPharma Product Testing Italy is notresponsible for airfare, hotel or other costs incurredby registered delegates. Your data will be processed in accordance with EUregulation no. 679 of 27 April 2016 and LegislativeDecree 30 June 2003, n. 196.By sending this form, you confirm that you haveread and accepted the Terms and Conditions.