CONFERENCEBROCHURE

Regulatory event for CEE region

Annual Eastern Europe Regulatory Conference

Registration of Plant Protection Products – Between Regulatory Framework and Reality Challenges

9.-10. April 2019

830-930 REGISTRATION

930-940 10’ Welcome from HU MoA Geza Gabriel MoA, Department of Food Chain Control, Plant Protection and Soil Conservation Division, Deputy Head of Department, Chief Plant Officer

940-1010 30’ KEYNOTE PRESENTATION: EU legal framework – current issues and challenges (remote presentation) Dr. Klaus Berend EU COM, DG Health and Food Safety, Unit E.4 – Pesticides and Biocides, Head of Unit

1010-1030 20’ HU - local challenges NEBIH view Dr. Gábor Tőkés NEBIH, Directorate of Plant Protection, Soil Conservation and Agri-Environment, Deputy Director

1030-1100 30’ COFFE BREAK

1100-1120 20’ Improvement of the availability of active substances and the linkage between approval and authorisation procedure Dr. Martin Streloke Federal Office of Consumer Protection and Food Safety, Division “Plant Protection Products” (BVL), Head of the Department

1120-1140 20’ A.s. review challenges and possible improvements Dr. Luuk van Duijn Board for the authorisation of plant protection products and biocides (CTGB), Executive Director

1140-1200 20’ Consequences of a.s. withdrawals for agriculture Szalkai Gábor Hungarian Crop Protection Association (HuCPA), Managing Director

1200-1220 20’ Minor uses Jeroen Meeussen EU Minor Uses Coordination Facility, Coordinator

1220-1230 10’ Q & A

1230-1400 90’ LUNCH BREAK

1400-1420 20’ Bioproducts David Carry International Biocontrol Manufacturers Association (IBMA), Executive Director

1420-1440 20’ Biopesticides versus conventional pesticides – regulatory challenges Dr. Agata Jakubowska Applied Insect Science S.L., Project Manager and Regulatory Expert

1440-1500 20’ New strategies of biological pest control Murielle Alazet Oro Agri International Ltd., Regulatory Manager

1500-1520 20’ New EU fertilisers regulation Beata Cebere Agrinos AS, Regulatory Affairs Manager

1520-1600 40’ COFFE BREAK

1600-1620 20’ REFIT Hans Mattaar ECCA, Technical director

1620-1640 20’ Streamlining the authorisation procedure of PPPs Dr. Jose Joao Carvalho knoell Germany GmbH, Head of Business Development Crop Protection

1640-1700 20’ Q & A

REGISTRATION

INTRODUCTION

A.S. EVALUATION AND WITHDRAWAL

BIOPRODUCTS

EU regulatory environment and changes

(BREXIT, REFIT)

Chair person for the Session: Bojana Zgonec,

Artemisa Slovenia

Chair person for the Session: Dr. Gábor Tőkés, NEBIH Hungary

Chair person for the Session: Dr. Jose Joao Carvalho, knoell Germany GmbH

900-920 20’ The impact of Brexit on the regulation of plant protection products in the EU Dr. Irene McGrath Kerona Scientific Ltd., Managing director

920-940 20’ EU dispute resolution and other legal challenges for PPP companies Peter Kugel VVGB Advocaten Brussels, Partner

940-1000 20’ Poison Centre Notifications as of 2020. Impact on PPPs Daniel Sompolski ECHA, Scientific officer and expert in Poison Centres

1000-1030 30’ COFFE BREAK

1030-1050 20’ Present situation and future of PPP SK Lenka Gurská Krajčovičová Central Control and Testing Institute in Agriculture in Bratislava (ÚKSÚP), Department of pesticides registration, Coordinator of Expert Evaluations

1050-1110 20’ Present situation in Czech Republic Ing. Pavel Minar, PhD. State Phytosanitary Administration, Central Institute for Supervising and Testing in Agriculture, Head of the Department

1110-1130 20’ Present situation in France Amélie Grimaldi Staphyt Regulatory, Senior Regulatory Consultant

1130-1150 20’ Present situation in Poland Aleksandra Gniado Artemisa Poland, Senior Regulatory Expert

1150-1200 10’ Q & A

1200-1330 90’ LUNCH BREAK

1330-1350 20’ Present situation in Italy Dr. Maristella Rubbiani National Centre for Chemicals, Dangerous Preparations and Mixtures, Head of the Unit

1350-1410 20’ Croatian Experience and Current Status in Registration Procedures of PPPs Dr. Zdravka Sever Croatian Agency for Agriculture and Food (HAPIH), Head of department for PPP and biocides

1410-1430 20’ Present situation in Montenegro Zorka Prljević Directorate for Foodsafety, Veterinary and Phytosanitary Affairs, Montenegro, Deputy Director

1430-1500 30’ COFFE BREAK

1500-1520 20’ Everyday regulatory challenges in Albania Amedeo Kola Ministry of Agriculture and Rural Development of Albania (MARDA), PP Specialist

1520-1540 20’ PPP registration system in Moldova in connection with EC regulation Maria Stroiu State Centre for Certification and Approbation of Phyto-sanitary Means and Fertilizers of the Republic of Moldova, Head of General Department

1540-1555 15’ Q & A

1555-1630 35’ Conclusions of the conference

1630 Conference closing

EU regulatory environment and changes

COUNTRY REPORTS, Art. 43 renewal challenges

Chair person for the Session: Christoph Weber, Albaugh Europe Sàrl

COUNTRY REPORTS

Chair person for the Session: Liana Skok, Artemisa Slovenia

COUNTRY REPORTS, Art. 43 renewal challenges

Chair person for the Session: Viktor Prachar, Artemisa Slovakia

Chair person for the Session: Dr. Zdravka Sever, HAPIH Croatia

Dr. Klaus Berend EU COM, DG Health and Food Safety, Unit E.4 – Pesticides and Biocides, Head of Unit

Dr. Klaus Berend joined the European Commission in 1994 and is currently Head of Unit in the European Commission’s Directorate-General Health and Food Safety, responsible for the implementation of the Pesticides and Biocides legislation.Before, he was Head of Unit in the European Commission’s Directorate-General Internal Market, Industry, Entrepreneurship & SMEs, in charge of the implementation of the EU Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Previously, he was Head of Unit in DG Enterprise & Industry, responsible for EU legislation on the Classification, Labelling and Packaging of substances and mixtures (CLP), Good Laboratory Practices (GLP), detergents, fertilisers, drug precursors, explosives and pyrotechnic articles. The Unit also dealt with the sustainability and competitiveness of the chemicals industry in the European Union.Earlier, he was Deputy Head of Unit in the Commission’s Directorate General for Environment, Unit Biotechnology & Pesticides, where he co-ordinated the work concerning biocides, plant protection products and the Community’s participation in the Rotterdam Convention on Prior Informed Consent (PIC).He studied chemistry at the universities of Heidelberg, Freiburg, and Stanford, and obtained a PhD in polymer chemistry from the University of Freiburg (Germany).

Dr. Gábor Tőkés NEBIH, Directorate of Plant Protection, Soil Conservation and Agri-Environment, Deputy Director

Since November 2010, Gábor has been the Head of Authorization – he leads the department for PPPs and Yield Enhancers, and acts as Deputy Director of the Institute. He currently organizes the activities of three departments: Authorization, Evaluation and Plant Protection. Previous to his current role, he graduated as Biological Engineer from the Budapest Technical University. He gained his University doctor title at the Agricultural University of Gödöllő, in the topic of Growth regulators in cereal production. In 2004, he became member of EU Minor use working group.Since the first proposals he actively took part in the discussions about the new authorization regulation (1107/2009 EC).Since 2006 he has been dealing with authorization matters and has been responsible for re-registration of PPPs and registration of not PPPs (other products). He represented the Hungarian Authority in the Post Approval Issues WG, and on many conferences.

Dr. Martin Streloke Federal Office of Consumer Protection and Food Safety, Division “Plant Protection Products” (BVL), Head of the Department

Dr. Martin Streloke holds PhD of the University of Hannover in Zoology/Entomology. In the period between 1992 and 2002 he was responsible for regulatory risk assessment of aquatic organisms at national and EU level at BBA Braunschweig. Between 2002 and 2015 he was Head of the Department of Environment at BVL which included risk management of plant protection products in the frame of the authorization procedure. Since 2015 Dr. Streloke is Head of Department of the Federal Office of Consumer Protection and Food Safety, Division “Plant Protection Products (BVL) in Braunschweig. He is responsible for Preparation of EU-Guidance Documents and is chairing expert meetings for Annex-I listing of active substances. He is also member of OECD-Working groups and SETAC group.

OUR SPEAKERS / Day 1Tuesday, 9th April 2019

Dr. Luuk van Duijn Board for the authorisation of plant protection products and biocides (CTGB), Executive Director

Dr. Van Duijn (1953) has a master degree in plant pathology from Wageningen Agricultural University and a PhD in molecular virology from Utrecht University. He has a long career in public service, mainly with the ministry of Agriculture. He worked in several fields as policy advisor and head of department, a.o. In the field of Higher Education and Food Quality and as dept. director of Finance of the ministry. For 8 years he held several management positions in the Inspection Service for food and meat control (NVWA). Since 2013 he is executive director of the Dutch Competent authority for plant protection products and biocides and secretary to the Board.

Szalkai Gábor Hungarian Crop Protection Association (HuCPA), Managing Director

Current position of Mr. Szalkai Gábor is Managing Director of Hungarian Crop Protection Association (HUCPA), which represents the crop protection industry in Hungary. Members of HUCPA develop innovative and science-based solutions that keep crops healthy and contribute to provide Hungarians and Europeans a safe, affordable, healthy, and sustainable food supply. Gábor graduated at Szent István University and is holding MSc in agronomy with specialization in plant protection. He started his carrier in plant protection administration in the Central Service for Plant Protection and Soil Conservation. Before joining HUCPA in his position of Chief Plant Health Officer at the Ministry of Agriculture Gábor was responsible for Hungarian NAP and was supervising the plant health, plant protection and soil conservation system in Hungary for almost 6 years until end of 2016.

Jeroen Meeussen EU Minor Uses Coordination Facility. Coordinator

Jeroen Meeussen is a plant pathologist by training. On 1st September 2015 he started work as coordinator for the new EU Minor Uses Coordination Facility. From October 2010 till July 2015 Jeroen Meeussen has been working in Brussels for the European Commission (DG SANTE) on pesticide issues, including ‘minor uses’ and biopesticides. Before that he worked as the EU coordinator for plant protection products for the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb). Since 2005 Jeroen chairs the Expert Group on Biopesticides (EGBP) as part of the Pesticide Programme of the Organisation for Economic Co-operation and Development (OECD).

David Cary IBMA, Executive Director

Since 2010 David has been in place as the inaugural Executive Director of IBMA - this dynamic global trade association with a strong European focus. His career path has been focused on IPM, resistance management, implementation of biocontrol techniques, and systems based control of pests and diseases.David is passionate about reducing the reliance on traditional pesticides through finding, developing, registering and bringing to market new solutions to feed a growing world population whilst respecting biodiversity, the environment and protecting human health.David is an entomologist by training and spent several years co-ordinating, conducting, assessing, reporting efficacy trials and supervising regulatory compliance for biological agricultural inputs.

Dr. Agata Jakubowska Applied Insect Science S.L., Project Manager and Regulatory Expert

Agata Jakubowska holds a MSc degree in biotechnology from the University of Adam Mickiewicz in Poznan, Poland and a PhD degree in molecular virology from Wageningen Agricultural University, the Netherlands. Agata, originally Polish, has 15 years of research in biocontrol, in the Institute of Plant Protection in Poznan, Wageningen Agricultural University, the Netherlands, and University of Valencia, Spain. Her scientific experience includes use of baculoviruses, Bacillus spp and nematodes for biological control of pests and diseases. Since 2014 she is working as a regulatory expert, specialized in biopesticides. In 2018 she joined APIS Applied Insect Science, where she is responsible for the registration projects of biological active ingredients and products across Europe.

Murielle Alazet Oro Agri International Ltd., Regulatory Manager

Murielle is Regulatory Manager of Oro Agri International Ltd company since July 2012. Her career in the plant protection industry started in 1998 with a position of Assistant to the regulatory manager(s) for Europe and Africa and Middle East in Arysta Lifescience in France. In 2008 she joined AAKO BV company from The Netherlands as a Registration Manager for Africa and Middle East. After this four-year experience regarding chemical and biological products regulatory issues specific for mentioned regions of the globe her desire was to expand her know-how to biological products. Currently she is authoring and supporting application dossiers at European level both for the active substance and for the formulated products.

Beata Cebere Agrinos AS, Regulatory Affairs Manager

Beata Cebere earned her MSc degree in Biology and Biochemistry from the University of Latvia and a MSc in Environmental Sciences and Policy from the Central European University in Budapest (Hungary). Originally from Latvia, Beata started her career in Belgium in 2011 as European Environmental Health and Safety specialist for Chemadvisor, working with chemical regulations and hazard communication for Eastern European countries and Russia. In 2017 she joined Agrinos AS. Agrinos is producing biostimulants in USA and Mexico and sells their products in more than a dozen countries. Beata is responsible for the registration of Agrinos’ biostimulant products in European and CIS countries. She is also actively involved in the European Biostimulant Industry Council, the development of the new EU Fertilizer regulation and with that connected standardization process.

Hans Mattaar ECCA, Technical director

After graduating at Wageningen Agricultural University in 1984, Hans Mattaar joined Rhône-Poulenc Agro, in the position of Regulatory Affairs Expert for the Netherlands. From this position he moved on to the European Regulatory Team in 1992 as a coordinator for European regulatory affairs. During his career he expanded his area of interest from science to law, and from there it was a small step to the politics. He held the position of European Public & Governmental Affairs (PGA) Manager and Regulatory Strategy Manager for the last 7 years of his corporate career, while RPA merged with AgrEvo into Aventis CropScience, and then became part of Bayer CropScience. In January 2008 he left Bayer to pursue a career as Senior Advisor with Pappas & Associates, Attorneys at Law, in Brussels. In his current role he provides strategic and regulatory advice to businesses who operate in a regulated environment, both on operational and on organisational issues. In parallel to that he holds the position of Technical Director for ECCA, the European Association for the post-patent agrochemical industry, since June 2012, and for AgroCare, the Global Association for the post-patent industry since September 2016.

Dr. Jose Joao Carvalho knoell Germany GmbH, Head of Business Development Crop Protection

José Joao Carvalho (PhD Chemistry) is Head of Business Development and Regulatory Policy for Crop Protection at knoell Germany GmbH, an independent service provider for Regulatory Affairs and Product Registrations in the market for more than 20 years. With his regional teams, José is looking after new regulatory policies and guidance development in the different regions, focusing on regulatory frameworks impacting agriculture productivity: plant protection products (chemical and non-chemical solutions), new application technologies, plant heath & nutrition and soil health. Previously he was a European Regulatory Manager for crop protection products, coordinating active ingredient and product’s dossiers for approval by national regulatory agencies in different regions. He holds a PhD in Chemistry by the Humboldt University in Berlin and a Master in Pharmaceutical Sciences by Porto University in the field of animal immunology. José authored more than 10 articles in international peer-reviewed journals and 2 book chapter for the UK Royal Society of Chemistry, in the field of environmental contaminants. Before joining the private sector in 2011, he was a researcher in governmental institutions in Germany (Federal Institute for Materials Science and Testing, BAM), France (Institute for Agronomic Research, INRA) and Portugal.

Dr. Irene McGrath Kerona Scientific Ltd., Managing director

Irene is the Managing Director and senior regulatory consultant with Kerona Scientific Ltd., Irelands largest regulatory consultancy. Following a degree in analytical science and Ph.D. in chemistry, Irene started work on analytical method validation before moving into regulatory affairs over 26 years ago. She now leads a multidisciplinary and multilingual team of scientists managing Kerona’s client projects for the EU and Middle Eastern regions. Since Ireland is the only EU Member State with a land border with the UK, Brexit is a very hot topic for the country, and Kerona develops Brexit strategies for its biocide, chemical and plant protection clients based both in the UK and the EU.

Daniel Sompolski ECHA, Scientific officer and expert in Poison Centres

Daniel Sompolski joined the European Chemicals Agency (ECHA) in 2010 and is in charge of poison centres project under CLP Regulation since 2017. He is responsible for coordinating activities related to preparation of regulatory guidance, development of IT tools and stakeholders’ engagement. Earlier he was in charge of settling data-sharing disputes under REACH and Biocidal Products Regulation.Before joining the Agency, he worked at the Ministry of Agriculture in Warsaw in the area of authorisation of plant protection products. Mr Sompolski studied at the universities of Wrocław, Dresden and Vienna and holds a masters’s degree in chemistry. Mr Sompolski is Polish.

Lenka Gurská Krajčovičová Central Control and Testing Institute in Agriculture in Bratislava (ÚKSÚP), Department of pesticides registration, Coordinator of Expert Evaluations

Lenka works at the Department of pesticides registration of the Central control and testing institute in agriculture in Bratislava (ÚKSÚP). She is responsible for coordinating plant protection products registration process including communication with the applicants, member state authorities and expert institutes, incorporating the evaluation results in the label and processing the registration certificates.Before joining ÚKSÚP she worked in a testing laboratory conducting various chemical and ecotoxicological analyses.She holds a master´s degree in environmental ecology from the Pavol Jozef Šafárik University in Košice, Slovakia.

OUR SPEAKERS / Day 2Wednesday, 10th April 2019

Ing. Pavel Minar, PhD. State Phytosanitary Administration, Central Institute for Supervising and Testing in Agriculture, Head of the Department

Pavel is a MSc. graduate in horticultural production and holds a Ph.D. in Phytopathology from Mendel University in Brno. His career in plant protection started at an ornamental plants production facility, where he was responsible for growing technologies. In 1990 he joined the Czech PPP regulatory authority (Central Institute for Supervision and Testing in Agriculture) where he was involved in the field testing and evaluation of registration trials for 8 years. From 2000 onwards he was responsible for GEP certification and methodology for biological efficacy testing. From 2005 he is the Head of the PPP Branch of the Central Institute for Supervision and Testing in Agriculture (UKZUZ) responsible for the authorisation process and for post-registration inspections of pesticides. He represents the Czech Republic at the Standing Committee for the Food Chain and Animal Health and at EU Council Working Groups.

Amélie Grimaldi Staphyt Regulatory, Senior Regulatory Consultant

Amélie Grimaldi is the reference senior regulatory consultant within Staphyt Regulatory, a European Consultancy Company which has existed for 20 years. Following a master’s degree in agronomy and in analytical chemistry (AgroParisTech), Amélie started work in a laboratory for the chemical analysis of food matrices. She then joined, as junior consultant, a French Consultancy Company (Ambrosi Scientific Consulting which became Staphyt Regulatory in 2015-17). For over 17 years, she has specialised in residues, e-fate modelling and regulatory strategy and submissions. She is now the regulatory reference for regulatory strategy for European stakeholders within Europe. Amélie is also the technical adviser of the expert team of thePPP department in Staphyt Regulatory.

Aleksandra Gniado Artemisa Poland, Senior Regulatory Expert

Aleksandra Gniado is an experienced regulatory consultant who specializes in Plant Protection Products and Biocides Regulations in Poland. She started working for the chemical industry in 2008 offering support in marketing and regulatory affairs. She joined international regulatory consultancy in 2013 helping international companies place their products on the EU markets. She participated in numerous professional trainings in the field of law and science. Currently she works for Artemisa Poland as regulatory expert and project manager. Aleksandra has a degree in political science and environmental protection from University of Warsaw.

Dr. Maristella Rubbiani National Centre for Chemicals, Dangerous Preparations and Mixtures, Head of the Unit

Maristella has graduated in Biology and has a PhD in Industrial and Environmental Hygiene with an extensive experience in scientific issues related to phytosanitary legislation and risk assessment for plant protection products and biocides, spanning over 30 years.She is working at Istituto Superiore di Sanità (Italy) since 1986, currently in the position of Head of Unit for authorization of plant protection products and biocides according to EU procedures.She also records over 30 years of accomplishment working on EU chemical legislation and projects/programmes involving institutional development and capacity building especially in the area of implementing legislation related to chemicals. Additionally to that she has long experience in working as expert among scientific and official fora such as EU COM, ECHA, EFSA, OCSE, FAO, WHO and other international organisations.

Dr. Zdravka Sever Croatian Agency for Agriculture and Food (HAPIH), Head of department for PPP and biocides

Zdravka Sever is a Head of Department for Plant Protection Products and Biocides at Center for Plant Protection, Croatian Agency for Agriculture and Food. Her main activities are coordination and organization of evaluation process in authorization procedure of PPPs, biocides and active substances, communication and cooperation with Competent Authorities on national and EU level as well as with applicants and experts involved in assessment. She is also expert for evaluation of PPPs in the field of residues and analytical methods for determination of residues. Previously, Zdravka Sever worked as Young researcher at University of Zagreb, Faculty of Agriculture, Department of Plant Pathology, where she was involved in research of plant pathogenic fungi and participated in lectures for students. Her educational background includes Graduate studies “Plant Protection” and Postgraduate doctoral studies “Agricultural Sciences” from the scientific field Biotechnical sciences, Agriculture, Phytomedicine.

Zorka Prljević Directorate for Foodsafety, Veterinary and Phytosanitary Affairs, Montenegro, Deputy Director

Zorka Prljević is a Deputy Director for phytosanitary policy in Directorate for Foodsafety, Veterinary and Phytosanitary Affairs in Montenegro. Her main activities are coordination and organization of working process in the following areas: plant health, PPPs, fertilizers, seeds and seadling material and organization of work of phytosanitary inspection in Montenegro. She is also chief of negotiating group fot Chapter 12 Food safety, veterinary and phytosanitary policy and member of team for authorization/recognition of PPPs in Montenegro. Previously, Zorka worked as director of Phytosanitary administration and as adviser to the Ministry of agriculture, where she was involved in all parts of phytosanitary activites. She is also active as external lecturer at the Faculty of Food Technology, Food Safety and Ecology, University of Donja Gorica- Podgorica, Montenegro.

Amedeo Kola Ministry of Agriculture and Rural Development of Albania (MARDA), PP Specialist

Mr. Amedeo Kola, BSc. is Plant Protection Specialist involved in plant protection products evaluation and registration at the Ministry of Agriculture, Rural Development and Water Administration of Albania (MARDA). He is responsible for registration and renewal of PPPs as well as for regular update of the list of products used in biological agriculture. His professional activity includes active involvement in the preparation of legislative acts in the area of plant protection product.He is also active as external lecturer at the Department of Plant Protection of Agricultural University of TIRANA.

Maria Stroiu State Centre for Certification and Approbation of Phyto-sanitary Means and Fertilizers of the Republic of Moldova, Head of General Department

Maria Stroiu gained her Bachelor degree in agronomy, specialization in plant protection and Master degree in integrated plant protection from the State Agrarian University of the Republic of Moldova.After graduation of University, she joined the State Centre for Certification and Approbation of Phyto-sanitary Means and Fertilizers, as a specialist coordinator, and since 2010 she has been Head of General Department.Her knowledge of European and CIS countries registration procedures of PPP and fertilizers permits her to better explain to applicants the Moldavian registration process and requirements. She is involved in checking of completeness and data quality as well as evaluating of PPPs dossiers submitted for registration. Since 2014, she has been dealing with transposing of EU regulations on plant protection products, fertilizers and chemical substances to Moldovan legislation, joint wok with Ministry of Agriculture, Rural Development and Environment.

Ing. Pavel Minar, PhD. State Phytosanitary Administration, Central Institute for Supervising and Testing in Agriculture, Head of the Department

Pavel is a MSc. graduate in horticultural production and holds a Ph.D. in Phytopathology from Mendel University in Brno. His career in plant protection started at an ornamental plants production facility, where he was responsible for growing technologies. In 1990 he joined the Czech PPP regulatory authority (Central Institute for Supervision and Testing in Agriculture) where he was involved in the field testing and evaluation of registration trials for 8 years. From 2000 onwards he was responsible for GEP certification and methodology for biological efficacy testing. From 2005 he is the Head of the PPP Branch of the Central Institute for Supervision and Testing in Agriculture (UKZUZ) responsible for the authorisation process and for post-registration inspections of pesticides. He represents the Czech Republic at the Standing Committee for the Food Chain and Animal Health and at EU Council Working Groups.

Amélie Grimaldi Staphyt Regulatory, Senior Regulatory Consultant

Amélie Grimaldi is the reference senior regulatory consultant within Staphyt Regulatory, a European Consultancy Company which has existed for 20 years. Following a master’s degree in agronomy and in analytical chemistry (AgroParisTech), Amélie started work in a laboratory for the chemical analysis of food matrices. She then joined, as junior consultant, a French Consultancy Company (Ambrosi Scientific Consulting which became Staphyt Regulatory in 2015-17). For over 17 years, she has specialised in residues, e-fate modelling and regulatory strategy and submissions. She is now the regulatory reference for regulatory strategy for European stakeholders within Europe. Amélie is also the technical adviser of the expert team of thePPP department in Staphyt Regulatory.

Aleksandra Gniado Artemisa Poland, Senior Regulatory Expert

Aleksandra Gniado is an experienced regulatory consultant who specializes in Plant Protection Products and Biocides Regulations in Poland. She started working for the chemical industry in 2008 offering support in marketing and regulatory affairs. She joined international regulatory consultancy in 2013 helping international companies place their products on the EU markets. She participated in numerous professional trainings in the field of law and science. Currently she works for Artemisa Poland as regulatory expert and project manager. Aleksandra has a degree in political science and environmental protection from University of Warsaw.

Dr. Maristella Rubbiani National Centre for Chemicals, Dangerous Preparations and Mixtures, Head of the Unit

Maristella has graduated in Biology and has a PhD in Industrial and Environmental Hygiene with an extensive experience in scientific issues related to phytosanitary legislation and risk assessment for plant protection products and biocides, spanning over 30 years.She is working at Istituto Superiore di Sanità (Italy) since 1986, currently in the position of Head of Unit for authorization of plant protection products and biocides according to EU procedures.She also records over 30 years of accomplishment working on EU chemical legislation and projects/programmes involving institutional development and capacity building especially in the area of implementing legislation related to chemicals. Additionally to that she has long experience in working as expert among scientific and official fora such as EU COM, ECHA, EFSA, OCSE, FAO, WHO and other international organisations.

Dr. Zdravka Sever Croatian Agency for Agriculture and Food (HAPIH), Head of department for PPP and biocides

Zdravka Sever is a Head of Department for Plant Protection Products and Biocides at Center for Plant Protection, Croatian Agency for Agriculture and Food. Her main activities are coordination and organization of evaluation process in authorization procedure of PPPs, biocides and active substances, communication and cooperation with Competent Authorities on national and EU level as well as with applicants and experts involved in assessment. She is also expert for evaluation of PPPs in the field of residues and analytical methods for determination of residues. Previously, Zdravka Sever worked as Young researcher at University of Zagreb, Faculty of Agriculture, Department of Plant Pathology, where she was involved in research of plant pathogenic fungi and participated in lectures for students. Her educational background includes Graduate studies “Plant Protection” and Postgraduate doctoral studies “Agricultural Sciences” from the scientific field Biotechnical sciences, Agriculture, Phytomedicine.

Zorka Prljević Directorate for Foodsafety, Veterinary and Phytosanitary Affairs, Montenegro, Deputy Director

Zorka Prljević is a Deputy Director for phytosanitary policy in Directorate for Foodsafety, Veterinary and Phytosanitary Affairs in Montenegro. Her main activities are coordination and organization of working process in the following areas: plant health, PPPs, fertilizers, seeds and seadling material and organization of work of phytosanitary inspection in Montenegro. She is also chief of negotiating group fot Chapter 12 Food safety, veterinary and phytosanitary policy and member of team for authorization/recognition of PPPs in Montenegro. Previously, Zorka worked as director of Phytosanitary administration and as adviser to the Ministry of agriculture, where she was involved in all parts of phytosanitary activites. She is also active as external lecturer at the Faculty of Food Technology, Food Safety and Ecology, University of Donja Gorica- Podgorica, Montenegro.

Amedeo Kola Ministry of Agriculture and Rural Development of Albania (MARDA), PP Specialist

Mr. Amedeo Kola, BSc. is Plant Protection Specialist involved in plant protection products evaluation and registration at the Ministry of Agriculture, Rural Development and Water Administration of Albania (MARDA). He is responsible for registration and renewal of PPPs as well as for regular update of the list of products used in biological agriculture. His professional activity includes active involvement in the preparation of legislative acts in the area of plant protection product.He is also active as external lecturer at the Department of Plant Protection of Agricultural University of TIRANA.

Maria Stroiu State Centre for Certification and Approbation of Phyto-sanitary Means and Fertilizers of the Republic of Moldova, Head of General Department

Maria Stroiu gained her Bachelor degree in agronomy, specialization in plant protection and Master degree in integrated plant protection from the State Agrarian University of the Republic of Moldova.After graduation of University, she joined the State Centre for Certification and Approbation of Phyto-sanitary Means and Fertilizers, as a specialist coordinator, and since 2010 she has been Head of General Department.Her knowledge of European and CIS countries registration procedures of PPP and fertilizers permits her to better explain to applicants the Moldavian registration process and requirements. She is involved in checking of completeness and data quality as well as evaluating of PPPs dossiers submitted for registration. Since 2014, she has been dealing with transposing of EU regulations on plant protection products, fertilizers and chemical substances to Moldovan legislation, joint wok with Ministry of Agriculture, Rural Development and Environment.

Bojana ZgonecManaging Director Prior to founding Artemisa in 2018, Bojana worked for TSGE as managing director between 2009-2018, for Bayer CropScience as a registration manager and then as a registration manager for Pinus TKI d.d. In 2006, she moved in to a regulatory consultancy role where she gained extensive experience in regulatory affairs and business development covering Eastern Europe. Her carrier is a blend of working experience with multinational company, local generic company and associate cooperation with a partner linked with the self-employer status experience. As Managing Director of Artemisa she has created a successful network of offices in Slovenia, Poland and Slovakia with dedicated team of experts.

Liana SkokPrincipal Expert Liana is a Principal Expert with extensive knowladge on national registration requirements in the Eastern European and Balkan region legislation and liaises with regulatory authorities. She is fluent in Slovenian, English, German, Croatian and Serbian and has basic understanding of Macedonian.She gained experiances as PPP registration manager in Ciba, Novartis, Syngenta and TSGE company as person responsible for registration work in the ex-Yugoslavian countries (Slovenia, Croatia, Bosnia, Macedonia, Kosovo, Serbia and Albania).

Dr. Lucija LeskovšekSenior Expert Lucija has a PhD in Agronomy-Biotechnology. After her PhD she started working as a researcher in the field of breeding of genetic fundamental hop material. While working at Slovenian Institute for Hop research and Breeding she was actively involved in public service for forecasting in plant protection as well as planning and evaluation of biological efficacy trials. She has gathered experience and has strengthen her skills in the plant health protection as a plant protection specialist holding that position for the next few years. In 2013 she took the opportunity and started working in BASF Slovenia as a country registration manager responsible for plant protection products and biocides registration in Slovenia and Croatia. With her knowledge in plant health protection and in regulatory affairs she joined consulting company TSGE and recently ARTEMISA regulatory team. Since joining ARTEMISA consulting company she provides support for all procedures related to PPP and biocides registration.

Petra JanežičSenior Expert Petra is a Senior Expert with knowledge on biocide national registration requirements and poison centre notifications in the Central and Eastern European region covering Bulgaria, Croatia, Estonia, Latvia, Lithuania, Romania, Serbia and Slovenia. She liaises with regulatory authorities, communicates with clients and provides project management services. Prior to joining Artemisa she gained experience with the 6 years of regulatory work in the TSGE consulting company.

Dr. Viktor PracharPrincipal Expert, Slovakia Viktor has many years’ experience from science and research in the areas of Plant Protection Products and analytical chemistry of xenobiotics. For eight years he has been acquired at senior management level in the SK National Reference Centre for Pesticide Residues and published a number of scientific papers in international CC journals. Later as senior executive he joined the Centre for Chemical Substance and Preparations where he was Head of the Biocides Unit, national Competent Authority for Biocides. For 10 years Viktor was national representative at the EU CA meetings and Standing Committee for Biocidal Products. Viktor is Associated Professor at the Slovak University of Technology. In 2014 he moved to regulatory consultancy and joined TSGE. Since June 2018 is Viktor with Artemisa in position of Principal Regulatory Expert BP and PPP Slovakia and Czech Republic.

Dr. Emília Kotrusz BúriováRegulatory expert, Hungary Emilia is a Regulatory consultant responsible for registrations of biocidal products, hazardous materials and plant protection products in Hungary, Slovak and Czech Republic. She gained experience with the regulatory work working in the Ministry of Economy, Centre for Chemical Substances and Preparations in Bratislava and working at Joint Research Centre of the European Commission in Italy.She has a PhD in Nuclear Chemistry from the Comenius University of Bratislava.

Martina Drličkova, Dipl. Ing., PhD.Regulatory Expert Martina is a Regulatory consultant responsible for registrations of biocidal products, hazardous materials and plant protection products in Slovak and Czech Republic. She provides support to clients on national registration processes and liaises with SK and CZ regulatory authorities.Previously she worked in research laboratory at Slovak Medical University, following 5 years in the Slovak Authority for REACH, CLP, detergents and biocidal products at Ministry of Economy in Bratislava, where she gained experience with the regulatory work. She was involved in REACH substances and dossier evaluation, manual screening and hazard assessment of substances. She also participated in two working groups dealing with implementation of nanomaterials in REACH (CASG NANO and ECHA NMWG). Martina has a degree in Biochemistry and Biotechnology from the Slovak Technical University and PhD in Public Health from the Slovak Medical University.

Aleksandra GniadoSenior Regulatory Expert Aleksandra is an experienced regulatory consultant who specializes in Plant Protection Products and Biocides Regulations in Poland. She started working for the chemical industry in 2008 offering support in marketing and regulatory affairs. She joined international regulatory consultancy in 2013 helping international companies place their products on the EU markets. She participated in numerous professional trainings in the field of law and science. Currently she works for Artemisa Poland as regulatory expert and project manager. Aleksandra has a degree in political science and environmental protection from University of Warsaw.

Elżbieta LipskaRegulatory Expert Elżbieta Lipska has a MSc degree in biology from the University of Bialystok, Poland. She was working for over 7 years in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Warsaw where she was involved in evaluation of biocidal active substances under the EU Review Programme and biocidal products under national and European registration procedures. She was a representative of the polish authority in many European working groups and participated in professional courses in the field of science and regulations.In 2015 she joined TSGE, an international regulatory consulting company, where she was responsible for the registration projects of biocidal products and plant protection products in Poland.Elżbieta works for Artemisa Poland as project manager and regulatory expert providing regulatory consultancy for biocidal and plant protection products registrations on the Polish market.

Mouhoube Ako Spiess-Urania Chemicals GmbH

Murielle Alazet Oro Agri International Ltd

Emanuela Andreini Diachem SpA

Klaus Berend European Commission, DG Health and Food Safety

Oliver Berndt W. Neudorff GmbH KG

Ruth Bürger Detia Freyberg GmbH

Luke Cartwright TSG Consulting Ltd

David Cary International biocontrol manufacturers association

Carlotta Casalegno Finchimica SpA

Beata Cebere Agrinos AS

Martina Drličkova Artemisa d.o.o.

Gloria Dutu ADAMA Agricultural Solutions Srl Romania

Sherin Fashanu Spiess-Urania Chemicals GmbH

Lisette Feher Linge Agroconsultancy B.V.

Agnes Fejes Polgar ACRO Kft.

Marta Galusová Central Control and Testing Institute in Agriculture, Slovakia

Aleksandra Gniado Artemisa d.o.o.

Aleksandra Gniado ARTEMISA d.o.o. Sp. z o.o. Oddział w Polsce

Kateryna Golovenets ADAMA Agriculture B.V. Schaffhausen Branch

Kathryn Gouldsbury Barclay Chemical Manufacturing Ltd.

Amélie Grimaldi Staphyt Regulatory

Lenka Gurská Krajčovičová ÚSTREDNÝ KONTROLNÝ A SKÚŠOBNÝ ÚSTAV POĽNOHOSPODÁRSKY V BRATISLAVE

Sophie Hane-Weijman FMC Agricultural Solutions

Nicolas Harmel Redebel Regulatory Affairs SCRL

Nicolas Huguet Action Pin SA

Agata Jakubowska Applied Insect Science S.L.

Petra Janežič Artemisa d.o.o.

Sonja Jaschke Spiess-Urania Chemicals GmbH

Jana Ježkova CERTIS EUROPE B.V.

José Joao Carvalho knoell Germany GmbH

Elzbieta Kalinowska SBM Développement SAS

Sandor Karikas REGULATORING SV

Thomas Klug W. Neudorff GmbH KG

Amedeo Kola Ministry of Agriculture, Rural Development and Water Administration of Albania

Ludek Krehlik ADAMA CZ s.r.o.

Peter Kugel VVGB Advocaten/Avocats

Jennifer Kunze Detia Freyberg GmbH

Lucija Leskovšek Artemisa d.o.o.

Elzbieta Lipska Artemisa d.o.o.

Nataliia Liubach ADAMA Agriculture B.V. Schaffhausen Branch

Maja Majdič Artemisa d.o.o.

Antonela Majić CONAGRA REG d.o.o.

Hans Mattaar European Crop Care Association aisbl

Irene McGrath Kerona Scientific Ltd.

Jeroen Meeussen EU Minor Uses Coordination Facility

Pavel Minar State Phytosanitary Administration, Central Institute for Supervising and Testing in Agriculture

Edwuin Rios Hander Morales Helm AG

Geoffroy Moulin Staphyt Regulatory

Diana Nakunst Spiess-Urania Chemicals GmbH

Alexandra Neagu ADAMA Agricultural Solutions Srl Romania

Tatjana Palcseh Polgar ACRO Kft.

Grazyna Panek-Minkin APC Ltd

Milka Petrušić Directorate for Foodsafety, Veterinary and Phytosanitary Affairs, Department for Plant Protection, Montenegro

Krystyna Pikulik Gowan Crop Protection Limited

Viktor Prachar Artemisa d.o.o.

Zorka Prljević Directorate for Foodsafety, Veterinary and Phytosanitary Affairs

Ivana Radivojević Galenika-Fitofarmacija a.d.

Daliborka Reković Galenika-Fitofarmacija a.d.

Caroline Rolin Redebel Regulatory Affairs SCRL

Maristella Rubbiani Center for chemicals, cosmetics and consumer protection, Istituto Superiore di Sanità

Zdravka Sever Hrvatska agencija za poljoprivredu i hranu, Centar za zaštitu bilja

Alexandra Sirko LLC "Adama Rus"

Liana Skok Artemisa d.o.o.

Daniel Sompolski European Chemicals Agency

Milica Stević Galenika-Fitofarmacija a.d.

Martin Streloke Office of Consumer Protection and Food Safety, Division “Plant Protection Products" (BLV)

Maria Stroiu State Centre for Certification and Approbation of Phyto-sanitary Means and Fertilizers of the Rep. of Moldova

Claudia Studart-Witkowski Helm AG

Jacqueline Suess APIS Applied Insect Science GmbH

Gábor Szalkai Hungarian Crop Protection Association

Ewa Tabor Esticon Tabor sp. j.

Brian Thomson Exponent International Ltd

Gábor Tőkés National Food Chain Safety Office, Directorate of Plant Protection, Soil Conservation and Agri-Environment

Luuk van Duijn Board for the authorisation of plant protection products and biocides

Esmeralda van Strien Afepasa, SAU

Christoph Weber Albaugh Europe Sàrl

Louis Wyness TSG Consulting Ltd

Bojana Zgonec Artemisa d.o.o.

DELEG

ATE LIST

APIS is a full service company that can take control of your registration project for you. With proven relationships at every level, you can trust APIS to deliver your project with minimal input. We have a team of experts in all fields covering all data requirements for active substance and plant protection products. Our mission is to provide tailored, time­ and cost­effective solutions. We work in a close relationship with our Clients to be able to respond to your needs. Timely and efficient communication is our priority.

OUR APPROACH WHAT WE DO

REGULATORY SERVICE • Full regulatory services for biopesticides and for conventional products • Data gap analysis and strategy development • Dossier preparation and subsequent dossier defence in the review process • Literature search according to EFSA Guidance Documentation work.

STUDIES • Lab and field bee studies, full range of NTA tests, microbial bioanalytics, 5­batch analysis and microbial contaminant screening, storage stability & phys­chem testing, non­target plant studies. • Studies for biopesticides and conventional products. • Almost anything out of the ordinary! If it’s not listed, just ask!

study or a full data package, regulatory advice or a complete submission,

SOUND GOOD SO FAR?

We love new clients and new challenges, so whether it’s a standalone

GET IN TOUCH TO SEE HOW WE CAN HELP YOU.

WE’RE DIFFERENT... With our long experience in the biopesticide industry and proven track record of developing microbial studies and negotiating pragmatic approaches with regulatory authorities, it’s no surprise that APIS has established itself as the partner of choice for some of the world’s largest crop protection companies and many innovative SMEs. The breadth of our biopesticide expertise is unrivalled, from regulatory problem­solving through to the design of complex studies to address unusual aspects of unique products. Our 100 percent success rate with studies and

dossiers submitted in the EU and US speaks for itself.

In 2018 APIS opened three new European offices – two in Germany and one in Spain – employing some of the world’s leading experts in the registration

of biopesticides.

+49 41 41 991 0384 www.appliedinsectscience.com enquiries@appliedinsectscience.com

Agrochemicals submissions

Fertilisers and supplementary soil substances

Adjuvants

Biopesticides submissions

Biocide submissions

REACH and industrial chemicals

Medical devices

Detergents

Classification and labelling

Strategic advice

Translation services

Training and events

EU: Slovenia, Croatia, Hungary,

Poland, Czech Republic,

Slovakia, Bulgaria, Romania,

Baltics, Italy, Greece, Austria

Beyond EU: Serbia, Bosnia,

Albania, Kosovo, Montenegro,

Macedonia, Turkey, Ukraine,

Russia, Moldova

ARTEMISAconsultancy services

Contact our offices in Slovenia, Slovakia, Poland or Hungary:

registrations@artemisa.si

Learn more about us at www.artemisa.si

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Experienced, reliable, fast and dedicated

LEGERA, Regulatory events, d.o.o.Cvetlična ulica 20

2270 OrmožSlovenia

info@legera.eu | www.legera.eu