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lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO 10-12 September 2019 Crowne Plaza Barcelona – Fira Center Barcelona, Spain STRENGTHEN YOUR CROP PROTECTION TOOL BOX THROUGH DEVELOPMENT, FORMULATION, AND REGULATION INSIGHTS Updates from the European Commission, Member States, EFSA and leading Industry Case Studies
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Page 1: STRENGTHEN YOUR CROP PROTECTION TOOL BOX THROUGH … · Latest advances in Biocontrol research: product development, modes of action, efficacy, application Manufacturing and Formulation

lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

10-12 September 2019 Crowne Plaza Barcelona – Fira Center Barcelona, Spain

STRENGTHEN YOUR CROP PROTECTION TOOL BOX THROUGH DEVELOPMENT, FORMULATION, AND REGULATION INSIGHTSUpdates from the European Commission, Member States, EFSA and leading Industry Case Studies

Page 2: STRENGTHEN YOUR CROP PROTECTION TOOL BOX THROUGH … · Latest advances in Biocontrol research: product development, modes of action, efficacy, application Manufacturing and Formulation

lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Pre-Conference Workshops • 10 September 2019

ENVIRONMENTAL RISK ASSESSMENT AND MODELLING REQUIREMENTS

REGULATORY REQUIREMENTS FOR BIOCONTROL

FOUNDATIONS OF AGROCHEMICAL FORMULATION: A BRIEF INTRODUCTION.

EFSA feedback on changes made to EU Guidance Documents • The current protection goals of EFSA for key guidance documents • The timelines of ongoing documents • Status of renewals for currently active guidance

Best practices for efficient Dossiers building for Biopesticides • Understanding the data requirements for biopesticides dossier application • Assessing the costs required for Dossier submissions

Introduction: Formulation is an essential value-adding step for agrochemical products. A good formulation will ensure that the active ingredient can be applied safely, economically, reproducibly and reliably with acceptable impact on the environment. Formulation can also provide new and improved benefits to the product and the user. In this interactive workshop we will provide a basic introduction to the main agrochemical formulation types and how they are made.

We will cover:• Relevant industry trends and drivers

• What is formulation - and why formulate?

• What are the main formulation types and why are there so many of them?

• How are formulations made and measured?

At the end of this session, participants will have a good basic knowledge of the main agrochemical formulation types, their pros and cons as well as an appreciation of how they are made.

Jim Bullock, Director, iFormulate Ltd

David Calvert, Director, iFormulate Ltd

Member State Guidance for Endocrine Disruptors for Fish • Understanding MS requirements for ED for Fish • Analysis for the test requirements

Commission Feedback: The outlook for Biocontrol for the next few years

Panel Endocrine Disruptor guidance for fish • Industry feedback on the approach for the Endocrine Guidance • Experiences with the two different approaches to testing ED

EFSA Update: Scientific evaluation of Biopesticides• Outlining the requirements of EFSA on Biopesticide testing• Future outlook at the guidance documents for Biopesticides • Highlighting the biggest areas of change for Biocontrol applications

Networking BreakEFSA Working group feedback on guidance’s of Birds and Mammals • Status of the current guidance document• Outline of the new requirements and new animals included• Best practices for testing requirements for Birds and Mammals

OECD Feedback: Understanding the data requirements for Microbial testing • Understanding Member State requirements for environmental assessment• Strategies to conduct the tests required to meet data points • Highlighting the changes between Biocontrol and Chemical Pesticide test packets

Analysis of TK/TD modelling for bird and Mammals • Best practices to conduct TK/TD modelling • Addressing concerns on testing for birds and mammals

Member state feedback on the bee guidance for Biocontrol• The current requirements for biocontrol to be compliant with bee guidance

Update: New Residue and Metabolism Guidance• Definition and outline of the guidance • Assessing the link between metabolism and residue• Requirements on Industry to comply to the guidance

Understanding the difficulties of testing micro-organisms on Aquatic Organisms • Understanding and overcoming the concerns with data requirements for Daphnids• What should be a more appropriate regulatory requirement to gain compliance?

Networking Lunch Latest opinion on the soil guidance • Explanation of the current guidance • Timeline of changes made to the guidance • Regulatory hurdles for compliance of the soil guidance

Industry Feedback on Aquatic

Identification of Metabolites in Environmental Fate• Best practices to identify metabolites• Successful testing results using new methods• Feedback on acceptance rates with member states

Dossier review • Showcasing successful dossier applications • Overview of the successful aspects • Working through examples of successful dossiersJeroen Meeussen, Coordinator, OECDRepresentative from EFSAThomas Preuss, Team-Leader Effect Modelling, Bayer CropScienceMaria Herrero, Director, Global Regulatory Affairs, Valent BioScienceNico Tan, Environmental Risk Assessor, CTGB

Panel Session: Risk assessment approach to hazard assessment approach • The concerns with the current assessment approach under 1107/09 • Potential alternative methods• Understanding the pros and cons of both methodsRepresentative from EFSAThomas Preuss,Team-Leader Effect Modelling, Bayer CropScienceAaldrik Tiktak, Senior Researcher, Soil and Water, PBLMark Miles, Pollinator Safety Specialist, BayerAnne Alix, Risk Manager, Corteva Nico Tan, Environmental Risk Assessor, CTGB

End of workshop 2

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3lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Main Conference

Wednesday 11 September 201908:00 Registration

AGCHEM FORUM: REGULATORY FRAMEWORKS

CROP PROTECTION FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

Annex II Procedure and criteria for approval (cut-off criteria) Guidance Plenary Session: Market trends

09:00 Feedback: Update on the status of the 1107/09 Refit • Process and next stepsEuropean Commission

Assessing the market trends of the Crop Protection industry • Evaluating global markets, developing trends and emerging needs• Classifying the impacts of mergers and acquisitions on the industry as a whole • Assessing the growing product types and the decreasing product types• Identifying leading Crop Protection trends

09:25 An update from EFSA on upcoming guidance documents • Update of upcoming guidance’s • Feedback on the status and timelines of NTA’s, Bee

guidance, worms • An opportunity to ask EFSA questions regarding the

regulatory landscapePending: EFSA

(09:35) Panel discussion: Discussing the trends of Agriculture – the future of farming • Understanding the requirements of the modern-day consumer• Hear current concerns regarding modern day farming methods and trends such as GMO, Organic and global warming• Outlook of the farming, and where the industry is moving Luc Peeters, Chairman of the WP, COPA-COGECA

09:50 The evaluation of the Dutch Pesticides Policy, which has close relationships with the REFIT processAaldrik Tiktak, Senior Researcher Soil and Water, PBL

10:15 Networking Refreshment Break

Co-Formulants and Annex 3 Latest advances in Biocontrol research: product development, modes of action, efficacy, application

Manufacturing and Formulation of RNAI to create stable, effective products

10:45 Challenges with Efficacy evaluation • Understanding the challenges with efficacy evaluation • Best practices to overcoming efficacy hurdlesNorbert Weissmann, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides, SCC

Case study for selecting new active ingredients to bring to market • Analysis of the research programme • Understanding the challenges of finding a new active • The efficacy and safety requirements of bringing a new product to market • Lessons learnt for future development of finding active ingredients Massimo Benuzzi, Technical Director, Biogard

Creating an effective manufacturing method of creating RNAI to ensure effective stability and delivery • Assessing which materials can be used for a successful

RNAI product • Analysing which materials needs to be used for

ensuring stable RNAI products • Ensuring an RNAI has effective shelf life capabilities

11:10 Member State feedback: The impact of Annex 3 • How to register co-formulants under REACH• The effect on workloads and timelines for MS • Feedback on applications submitted before Annex 3

Assessing the mode of actions of Microbials• Understanding the differences between different strands for the same microbials • Assessing the mode of action • Showcasing efficacy of new sources of microbes Inge Van Daele, Product Development Manager, Agrosavfe

Formulation strategies, such as encapsulation, to protect RNAI to ensure survival to the plant • Case study experience on how formulation can be used

to improve the uptake of RNAI to the plant • Strategies to protect naked RNAI to ensure efficacy

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4lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Main Conference

Wednesday 11 September 2019 (continued)

AGCHEM FORUM: REGULATORY FRAMEWORKS

CROP PROTECTION FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

Co-Formulants and Annex 3 Latest advances in Biocontrol research: product development, modes of action, efficacy, application

Manufacturing and Formulation of RNAi to create stable, effective products

11:35 Impact of banned Co-Formulants on industry • Assessing how to deal with re-submissions of altered

products without banned ingredients• Avoiding common pitfalls with co-formulants

registration • Feedback from industry on the impact of products

failing to make the cut of criteria Markus Fiess, Regulatory Product & Process Management, BASF, Germany

Latest’s science, latest projects: Understanding the properties of Pheromones• Understanding their application rate • Overview of mode of action • Case study results of efficacy - new science, new delivery methods. Alessandra Moccia, Regulatory Affairs, Senior Manager, Suterra

Using viruses as delivery mechanism for RNAi for more accurate results • Comparing viruses as a delivery mechanism to more

traditional methods of RNAi• Analysing the cell uptake of RNAi with viruses as

delivery method• Assessing the potential for different dosages with

viruses

12:00 Differences and overlap between review of actives under the agrochemicals and biocidal legislation• Understanding the cross over between regulations and

the impact of applying for co-formulant submittal • Assessing how the REACH application can help with

submitting co-formulants • Practical advice on applying multiple regulations to

co-formulantsIra Koval, Regulatory Affairs Specialist, Senior Toxicologist, Charles River

Development of a new Botanical Biofungicide• Example 7in registration processes

Achieving mobility while applying sprayable RNAi• Analysing which methods of delivery will allow for RNAi

mobility from roots to leave• Case study results of using sprayable RNAi for getting

good coverage of the plant

12:25 Q+A Session on Co-FormulantsMarkus Fiess, Regulatory Product & Process Management, BASF, GermanyIra Koval, Regulatory Affairs Specialist, Senior Toxicologist, Charles River

Q+A Session on latest advancements James Jimenez, Agronomist and Innovation Manager, Ecoflora AgroAlessandra Moccia, Regulatory Affairs, Senior Manager, SuterraInge Van Daele, Product Development Manager, AgrosavfeMassimo Benuzzi, Technical Director, BIOGARD

Q+A on RNAi

12:40 Networking Lunch in the Exhibition Hall

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5lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Main Conference

Wednesday 11 September 2019 (continued)

AGCHEM FORUM: REGULATORY FRAMEWORKS

CROP PROTECTION FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

ED Guidance Co-Formulants Adoption of Biocontrol for Farmers CRISPR

14:00 Implementation on new criteria to identify Endocrine Disruptors• First year of experience• Clarity on the approval process for new and pending

dossiersEuropean Commission

Stratagems to replace Co-Formulants that are on the non-approved list quickly and cost effectively• Addressing which co- formulants can no longer be used • What are the common replacements for these?• Methods for working out which co-formulant would make a good alternative on quick timeline and financially viable

Industry approaches to improving adoption of Biocontrol• Anticipate farmer needs 10-15 years from now• Disruptive technologies transforming big scale

agriculture in the short or long term. Are we prepared?• Discipline approach in Corteva to bring farmer focused

new innovation and technologiesCaroline Drummond, Chief Executive, LEAF

Feedback on what is available under the genome editing umbrella • A comparison of different CRISPR technologies and

their uses for crop protection• The efficacy of CRIPSR methods on different insect

types • Assessing which plant types reacted better to genome

editing tools such as CRISPR

14:25 Feedback on Endocrine Disruptors • Assessing the challenges with the first year of ED

guidance • Clarity on the approval process required for Endocrine

Disruptors• Looking at the impact of the ED Guidance on submitting

evaluationsMaristella Rubbiani, ISS, Italy

Formulation approaches using Co-formulants to create more efficient products • Understanding which co-formulants are used to

improve efficacy• Formulation strategies using co-formulants for

effective, safer crop protection • Increasing efficacy with first application of pesticides Spotlight Session

Assessing adoption hurdles of biocontrol with farmers • Understanding the biggest hurdles for farmers with

biocontrol as Crop Protection tool • Understanding the assessment criteria of farmers when

choosing their biocontrol productsMonica Sorribas, Global Seeds Program Management Leader, Corteva

Understanding how genome editing can be used for insect control development and the formulation strategies to achieve this • Case study using genome editing to better control

insect development • Formulation with CRISPR to create better insect

control products • Assessing the best formulation and application

combination for • Effective CRISPR insect controlPending: Thorben Sprink, Group Leader & Senior Scientist, Julius Kuehn Institute

ED Guidance Continued On target Delivery Development strategies to improve

and proof efficacy to increase uptake of Biocontrol

CRISPR Continued

14:50 Industry Experience: one year with Endocrine Disruptor guidance • Experiences with working with Endocrine Disruptor

Guidance • Assessing the challenges and concerns for following the

ED guidance• Evaluation responses for submitting co-formulantsMarkus Fiess, Regulatory Product & Process Management, BASF, Germany

Application and Management of Biopesticides for Efficacy and Reliability• Tools to ensure higher rates of on-target delivery• Challenges with the application of biopesticides.• Getting the most out of each application.Spencer Collins, Crop Protection Scientific Officer, Crop Health & Protection, AHDB

Increasing efficacy with Biocontrol Crop Protection to match synthetic crop protection • Formulation strategies to move efficacy from 40% to

80% on average• Tools needed to improve efficacyNarasimha Rao Kothapalli, President & Chief Executive Officer, Parry America Inc, USA

TALEN technologies • Development methods to reduce unwanted genomes• Assessing how TALEN improve the speed of plant

breeding • Understanding how to use TALEN

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6lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Main Conference

Wednesday 11 September 2019 (continued)

AGCHEM FORUM: REGULATORY FRAMEWORKS

CROP PROTECTION FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

ED Guidance Continued On target Delivery Development strategies to improve

and proof efficacy to increase uptake of Biocontrol

CRISPR Continued

15:15 Experiences creating dossiers for Endocrine Disruptors • Best practices for creating dossiers for Endocrine

Disruptors • Successful experiences with submitting ED applications • Avoiding the common pitfalls CITOXLABS

On Target Delivery to improve effectiveness of Pesticides • Formulation strategies to improve on target delivery• Case studies to show how penetrating the plant leaf

has altered delivery • Development of new technologies to improve delivery

to protect both the active but also ensure product only hits defined target

Spotlight Session

Understanding the requirements for conducting effective field trials that showcase the efficacy of biocontrol products • A step by step guide to run an effective field trial that

showcases efficacy of crop protection • Comparing different approaches of field studies: field trial

scale vs multiple sites/multiple years • Analysis of what is best in controlled condition for field trials • Understanding which scale should be used to prove the

efficacy of biocontrol productsMarcelo Labra, Field Trial Manager, Aphea Bio

Commercialising CRIPSR for crop protection • Understanding where the value for business is by using

genome editing technology • Understanding where the commercial hurdles are of

using Genome editing

15:40 Q+A on Endocrine Disruptor GuidanceCITOXLABSEuropean CommissionMaristella Rubbani

Q+A on-Target Delivery and Co-formulantsSpencer Collins, Crop Protection Scientific Officer, Crop Health & Protection, AHDB

Q+A Session on EfficacyMarcelo Labra, Field Trial Manager, Aphea BioNarasimha Rao Kothapalli, President & Chief Executive Officer, Parry America Inc, USA

Q+A on CRISPR

15:50 Networking Refreshment Break

Article 4(7) ApplicationDevelopment strategies to improve

and proof efficacy to increase uptake of Biocontrol

Plant Breeding techniques

16:20 Industry feedback on Article 4(7)• Results of an Article 4(7) application • Hurdles with submitting Article 4(7)• Sharing experiences with submitting article 4(7)

dossiers Garth Dury, GAB consulting

Assessing how Slow Control Release tools can be used to improve active application rates • Evaluating how Slow Control Release formulations can

alter release of active ingredients • Application methods to ensure actives are released at

the right time and remain effective for Crop ProtectionFideline Tchuenbou-Magaia, University of Wolverhampton

Natural extract vs. single compound active substance in biological plant protection products – Opportunities and regulatory challengesIndustry is looking for new tools for the control of diseases and pests with a beneficial profile in terms of human and environmental safety. Natural substances and micro-organisms are the key source in this context. However, increasing costs for burden of proof of their safety which is also applicable for such biorationals suggest the need for a careful analysis during the selection process and development of these alternatives. Some basic recommendations will be presented for further consideration by potential manufacturers Dr. Joachim Rumbolz, Regulatory Project Manager / Team Leader, Eurofins

Out of industry presentation: What can be learnt from Animal Breeding • Case study of gene editing with Cows and Pigs • How this can be transferred to plant breeding • What hurdles where overcome

Page 7: STRENGTHEN YOUR CROP PROTECTION TOOL BOX THROUGH … · Latest advances in Biocontrol research: product development, modes of action, efficacy, application Manufacturing and Formulation

7lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Main Conference

Wednesday 11 September 2019 (continued)

AGCHEM FORUM: REGULATORY FRAMEWORKS

CROP PROTECTION FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

Article 4(7) ApplicationDevelopment strategies to improve

and proof efficacy to increase uptake of Biocontrol

Plant Breeding techniques

16:45 Member state feedback on Article 4(7)• Understanding the requirements for restricted products

to qualify for approval under Article 4 (7)• Clarity on the assessment methods for Article 4 (7) by

Member States• Successful examples of products registered under

Article 4 (7)

The role of Application for effective on target delivery to avoid spray drift • Understanding how anti-drift nozzles can impact

delivery mechanisms • Creating safer products through application with less

spray driftProf.Dr. Daniel Bonn, Director, van der Waals-Zeeman Institute, University of Amsterdam

Early Plant nutrition and Pest Management for maximizing Crop Performance and yield• Maximum yield starts at planting with critical nutrients• This sets the trajectory for plant growth and meristem

formation.• A systems approach is necessary for proper nutrient

application all season.• Need to understand relationship between fertilization

and biologicals for season-long nutrient availability.• A field program to understand the effects of

biologicals and crop nutrients should include a deeper understanding of: crop needs, composition, packaging, application and ecosystem

Marco Toapanta, Global Director, Agrithority

Out of industry: What can be learnt from Medicine • Case study of gene editing with treating diseases in

humans • How this can be transferred to plant breeding • What hurdles where overcome

17:10 Article 4 (7) Q+A Garth Dury, GAB consulting

Application Q+AProf.Dr. Daniel Bonn, Director, van der Waals-Zeeman Institute, University of AmsterdamFideline Tchuenbou-Magaia, University of Wolverhampton

Efficacy Q+A Jennifer Lewis, Head of Portfolio, Certis UK

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8lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Main Conference

Thursday 12 September 2019AGCHEM FORUM:

REGULATORY FRAMEWORKS CROP PROTECTION

FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

1107/09 Feedback Best practices to create Combination products with Synthetics and Biologics

Genome and plant breeding technologies for effective crop

protection08:30 EFSA’s scientific viewpoint: Annex II

Procedure and criteria for approval (cut-off criteria)• Understanding the rationale behind non-approved

actives• Comprehensive look at list of non-approved actives

Highlighting the formulation strategies to create a combination product • Formulation challenges with mixing synthetic and biological actives• Assessing the stability issues with chemical and biological actives• Strategies to create stronger biocontrol products to ensure effective Crop Protection products overallPaula García Fraile, Independent Researcher

Nano particles as a delivery method for crop protection tools • Understanding the uses and basic principle of Nano

Particles as a delivery method for microbes and carriers• Practical feedback on the technologies uses and

capabilities • Case study on how to use and apply this technology to

crop protection

08:55 Member State requirements of non-approved actives in Annex II Procedure and criteria for approval (cut-off criteria)• Looking at the timelines of banned actives from guidance

to removal from shelves • Clarity on timeframe to reformulate a product• Status update on applications submitted before Annex 2

Hybrid Technology as a bridge from conventional to Biologicals in Crop ProtectionProfessor Moshe Reuveni, Chief Scientist, Stockton

Assessing Gene Drive as a novel technology for Crop Protection • Practical experience in applying gene drive technology

to a plant • Assessing the efficacy of gene drive tools in plants

instead of insects• Understanding how the technology works and the

fundamental science behind the technology

09:20 Legal impact of non-approval and how to legally challenge non approval AgChem Forum: Regulatory FrameworksClaudio Mereu, Joint Managing Partner, Field Fisher

Q+A Combination products with Synthetics and Biologics Professor Moshe Reuveni, Chief Scientist, StocktonPaula García Fraile, Independent Researcher

Impact of Brexit on the regulatory Landscape Actives and formulation stability

Genome and plant breeding technologies for effective crop

protection Cont.09:30 Q+A on Non approval Ensuring robust actives with serval ingredients for stronger crop protection

• Comparing different methods for combining several active ingredients• Better formulation techniques to ensure optimal results from each active• Avoiding common mistakes with producing multiple active productsSpotlight session

Addressing the ethical concerns regarding Gene drive technology • Understanding the potential side effects of using Gene

Drive as a Crop Protection tool• The ethical concerns of using gene drive as a crop

protection tool• In depth analysis of the dangers to a population

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9lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Main Conference

Thursday 12 September 2019AGCHEM FORUM:

REGULATORY FRAMEWORKS CROP PROTECTION

FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

Impact of Brexit on the regulatory Landscape Actives and formulation stability

Genome and plant breeding technologies for effective crop

protection Cont.9:55 Addressing stability concerns with multiple active ingredients to create more stable final

product• Understanding the added stability problems with more than one active • Strategies to overcome stability issues with multiple actives• Formulation techniques to avoid stability challenges• Tools to maintain stability outside of the lab to increase shelf lifeDr. Jitendra Kumar, Director, Institute of Pesticide Formulation Technology

Heavy chain antibodies – target binding molecules• Methods of developing heavy chain antibodies which

stick to fungus in order to become sprayable • Case study of how heavy chain antibodies are currently

being used in Crop Protection and understanding how they can be used in the future

• Assessing the potential of protecting from more than just pests

10:20 Brexit Panel: First Experiences • Member State Viewpoint the process to deal with Brexit • First experiences and impacts of no-deal/deal Brexit• Industry concerns with Submissions without CRDChristian Prohaska, AGES, Austria

Understanding the potential of ensuring stability with Encapsulation • The effect of stability on biocontrol by encapsulating the active • Understanding which bacteria types can be encapsulated • Assessing effective methods to encapsulate Biocontrol especially bacteria• Understanding the current hurdles with encapsulation Josefina Barrera Cortes, Senior Researcher, Université Paris-Nord

Spotlight SessionIf you are interested in presenting as part of commercial package please contactDylan Smith, Business Development Executive on +44 (0) 20 3377 3237 [email protected]

10:55 View on the impact of Brexit on the European Submissions • The status of applications summited to CRD before

Brexit • Understanding the workload of upcoming submissions • The process for renewals of products originally

registered with CRDRepresentative from CRD

Actives and Stability Q+AJosefina Barrera Cortes, Senior Researcher, Université Paris-NordDr. Jitendra Kumar, Director, Institute of Pesticide Formulation Technology

11:05 Morning Coffee

Submission Feedback Low Risk Product requirements and possibilities

Regulatory impacts on genome editing and GMO products

11:35 Member State Feedback on Article 43• Current concerns with Article 43 • The impact on Brexit to the approval workloads • Current timelines with applications and renewals Dr. Katrin Franke, Unit Steering and Overall Assessment - Plant Protection Department Pesticides Safety, BfR. Germany

Testing the validation claims of Nano Particles as tool to create stronger formulations • Scientific approach to nano particles to prove

effectiveness • Field trial evidence to validate success claimsSavion Bar-Sever, Chief Executive Officer, Nano-CapSolution

Update on Low Risk substances • Clarity on the status of fast track registration for Low

Risk Molecules • Understanding the stages of implementation for Low

Risk• Addressing the impact of Low Risk Molecules with

ingredients from annex 1 listingBernd Brielbeck, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides, SCC

Feedback regarding ECJ judgement on genome editing • Following from ECJ judgement on genome editing,

what are the next steps for genome editing technology?• Viewpoint from the commission on this technology • Comparing the European pathway to the ROW

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Main Conference

Thursday 12 September 2019AGCHEM FORUM:

REGULATORY FRAMEWORKS CROP PROTECTION

FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

Submission Feedback Innovation in Crop Protection Low Risk Product requirements and possibilities

Regulatory impacts on genome editing and GMO products

11:55 Member State Feedback from Southern Zone• Updates on timelines from the Southern Zone• Viewpoint of Endocrine Disruptors for the Southern

Zone• Feedback on article 4(7) of 1107/2009José Luis Alonso-Prados, INIA

Presentation from BayerWilliam Abraham, Director, New Product and Process Technology, Bayer

Evaluating essential oils as an effective method for Crop Protection and overcoming volatility issues • Formulation techniques needed to overcome volatility• Best practices for extracting essential oils in

comparison to Botanicals• Assessing how they can be used as a co-formulant as

well as active extracting essential oils in comparison to Botanicals

Hugo Cores, Technical Marketing Manager, Development Department, LAINCO, Spain

Member State Feedback on Regulatory requirements for GE and GMO products • The current regulatory pathway for a genetically

engineered product • Understanding the application and labelling process • The risk assessment required under the GMO directive

12:20 Member State Feedback on the Northern Zone• Updates on timelines from the Northern Zone• Viewpoint of Endocrine Disruptors for the Northern

Zone• Feedback on article 4(7) of 1107/2009

Discovery of new Insecticides for Malaria Vector ControlPeter Maienfisch, Research Portfolio Manager Insect Control & Seedcare, Syngenta Crop Protection AG

Smart Bacillus-based formulations_successful solutions against diseases affecting row and cash cropsDr Noemí Herrero Asensio

Industry feedback on the regulatory requirements • Understanding the impact of being under the GMO

directive• Assessing the finical impact of new labelling • Addressing the long term view of working with GMO

12:55 ECPA feedback: Industry feedback on submissions• Update on the challenges for industry with submissions • Industry concerns of the regulatory landscape• Practical advice for navigating the regulatory landscape

for successful submissionsRepresentative from New UPL

Spotlight PresentationIf you are interested in presenting as part of commercial package please contactDylan Smith, Business Development Executive on +44 (0) 20 3377 3237 [email protected]

Development and formulation concerns for Botanicals • Assessing the complexities of a dry formulation • Improving the shelf life with dry formulations Spotlight Session

Spotlight PresentationIf you are interested in presenting as part of commercial package please contactDylan Smith, Business Development Executive on +44 (0) 20 3377 3237 [email protected]

1:20 Q+A on Submission FeedbackRepresentative from New UPLJosé Luis Alonso-Prados, INIA, SpainDr. Katrin Franke, Unit Steering and Overall Assessment - Plant Protection Department Pesticides Safety, BfR. Germany

Q+A in Crop ProtectionPeter Maienfisch, Research Portfolio Manager Insect Control & Seedcare, Syngenta Crop Protection AGWilliam Abraham, Director, New Product and Process Technology, Bayer

Q+A on Low Risk ProductsHugo Cores, Technical Marketing Manager, Development Department, LAINCO, SpainBernd Brielbeck, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides, SCC

1:30 Networking Lunch in the Exhibition Hall

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Main Conference

Thursday 12 September 2019AGCHEM FORUM:

REGULATORY FRAMEWORKS CROP PROTECTION

FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

Low Risk Substances Digital Farming Digital Farming

14:45 Experiences with data protection and data guidance’s with submissions • Understanding the guidelines with data protection with

submissions • Successful experiences with data with submissionsSpotlight sessions

Using Integrated Machine Intelligence to improve crop protection and production efficacies.Hungary Planet

Formulation requirements of successful seed coating with biocontrol • Understanding which types of actives respond best to

Seed Treatment application • The effect on the seed by having biocontrol treatments

applied • Assessing the relationship between chemical and

biological treatments on seed coating: Can both be applied together?

Spotlight Session

Understanding what is available for Digital Farming • Understanding the relationship between digital farming

and crop protection • What tools are available that will improve efficacy of

crop protection? • What can be learnt about the future of automation?Hungary Planet

15:10 Feedback from OECD on Minor Uses• Feedback from new Minor Uses Documents • The current outlines for a Minor Use Product• The impact of a regulation using a minor use productJeroen Meeussen, OECD

Formulation challenges with Digital Farming• How you apply and formulate different actives while

using Digital Farming as formulation tool • Creating products that can be altered to match

several different application methods such as; drone, automated sprays and automated tractors

• Assessing the volumes of product required when using Digital or Precision Farming

Effective strategies for applying Biocontrol to Seed Treatments • Assessing how to formulate biocontrol for seeds

treatments • Techniques for applying biocontrol to seed treatments • The formulation requirements for biocontrol to

effectively be applied to seed treatmentsDr. Ir. Ineke Wijkamp, Seed2Plant

Formulation challenges with Digital Farming• How you apply and formulate different actives while

using Digital Farming as formulation tool • Creating products that can be altered to match

several different application methods such as; drone, automated sprays and automated tractors

• Assessing the volumes of product required when using Digital or Precision Farming

15:35 Update on Low Risk substances• Clarity on the status of fast track registration for Low

Risk Molecules • Understanding the stages of implementation for Low

Risk • Addressing the impact of Low Risk Molecules with

ingredients from annex 1 listing. Rob van Drent, CTGB

Demonstrating digital farming methods that would improve the success of crop protection efficacy• Improving ROI of biopesticides with Digital farming

application methods• Assessing the impact on water management

Formulating to create products that meet the MRL requirements of Post-Harvest Biocontrol • Ensuring low MRLs on biocontrol products that are

designed for post-harvest use • How to ensure resistant free biocontrol products when

used post-harvest• Strategies to prevent resistance in products that are

solely used in post-harvest Pedro Juan, Country Manager, Certis Europe

Demonstrating digital farming methods that would improve the success of crop protection efficacy• Improving ROI of biopesticides with Digital farming

application methods• Assessing the impact on water management

16:00 Q+A on Minor Uses Rob van Drent, CTGBJeroen Meeussen, OECD

Q+A on Digital Farming Hungary Planet

Q+A Seed Pedro Juan, Country Manager, Certis EuropeDr. Ir. Ineke Wijkamp, Seed2Plant

Q+A on Digital Farming Hungary Planet

16:10 Networking Break

Page 12: STRENGTHEN YOUR CROP PROTECTION TOOL BOX THROUGH … · Latest advances in Biocontrol research: product development, modes of action, efficacy, application Manufacturing and Formulation

12lifesciences.knect365.com/cir/ @Crop_Chemical #CIRAGBIO

Main Conference

Thursday 12 September 2019AGCHEM FORUM:

REGULATORY FRAMEWORKS CROP PROTECTION

FORMULATION STRATEGIES BIOCONTROL NEW TECHNOLOGIES

Plenary Session: The effect of banning products on Crop Protection

16:50 Assessing the consequences of the non-approved products on Crop Protection • Understanding long term concerns of banning vital products

• The impact of farmers by banning essential crop protection products • Looking at alternative methods to increase safety and efficacy without banning products, with methods such as Digital Farming

17:20 Panel session: The role of public in Crop protection and methods to create positive engagement • Best practices to engage with the public regarding Crop Protection

• Reassessing the current methods for sharing information with the public• Highlighting the impact of NGOs and their successful campaigns educating the public

16:50 End of Conference

For sponsoring opportunities, please contact Dylan Smith: [email protected], +44 (0) 20 3377 3237

For speaking opportunities, please contact Rebecca Brady [email protected], +44 (0) 20 7017 5416


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