Crop Protection European Regulatory Conference

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Speakers in red are confirmed Crop Protection European Regulatory Conference 9 th -10 th March 2015 Hotel Le Plaza Boulevard Adolphe Max 118 B-1000 Brussels

March 9 th - Morning workshops 0900-1100 Conference Workshop 1 PPP authorisation management system (PPPAMS) training session (Chair: Aurélie Dhaussy?) Le Plaza, (Memling Room?) 0900 Welcome by Chairman 0910 Presentation of system 1000 Interactive question and answer session 1050 Conclusions 1100 Coffee break 0900-1100 Conference Workshop 2 Market update and agronomic and economic impact of current legislation (Chairman tbc?) Le Plaza, Theatre 0900 Welcome by Chairman 0910 European and global crop protection market update Matthew Phillips, PhillipsMcDougall 0940 Agronomic and economic impact of EU crop protection legislation tbc, Steward Redqueen 1010 Using data to support industry s political outreach Graeme Taylor, ECPA 1030 Question & Answer session 1100 Coffee break

March 9 th - Main Conference Le Plaza, Theatre from till 1130 1245 Opening session (Chairman Hans Mattaar) 1130 1140 Welcome by Chairman 1140 1200 Introductory comments by ECPA Crop protection industry outlook Beyond regulation: focus on stewardship efforts Medium term needs for an innovative sector Jean-Charles Bocquet, ECPA Director General 1200 1230 Dutch Presidency view: Greening of Sustainable Plant Protection Dutch Green deal initiative Initiatives in the EU working group Role of IPM and low-risk PPP s; Link to the review of 1107/2009 & 396/2005 Dr Susanne Sütterlin, Agriculture Directorate, Ministry of Economic Affairs 1230 1245 Question and answer session 1245 1345 Lunch 1345 1830 Session 1: Major legislative challenges for the crop protection industry 1345 1410 Status update on key elements in the implementation of Regulation 1107/2009 Key Challenges in the legislative implementation Milestones for 2016 Reviewing Regulations 1107/2009 & 396/2005 Wolfgang Reinert, DG SANTE 1410 1430 Regulation 1107/2009: Lessons learnt after 5 years? The challenges for legislative implementation in Germany What are the opportunities to shape and improve current implementation Possible future improvements through legislative changes Martin Streloke, BVL 1430 1450 Food & Veterinary Office view on implementation of Regulation 1107/2009 The role of the Food and Veterinary office in implementing PPP legislation Experience gained from the national inspections Areas for improvement applying and amending the legislation Dara O Shea, FVO 1450 1510 Review of 1107/2009: Industry view on future improvement options Key blockers for the generic industry Suggestions for future improvements Garth Drury, Rotam CropSciences 1510 1520 EU Minor Uses Coordination Facility History of the management of minor uses in the EU The current status of the Minor Use Coordination Facility

Medium-term focus of minor use work Jeroen Meeussen 1530 1600 Panel discussion 1600 1625 Coffee break Le Plaza, Gallery 1625 1645 EFSA s role in the evaluation of active substances Current evaluations and timelines Evaluation of new active substances Main issues identified in the evaluation of AIR-2 active substances Future challenges with AIR-3, AIR-4 and new ASs Jose Tarazona or Bénédicte Vagenende, EFSA 1645 1705 Decision making for new and review active substances Current status of decision making Main blockers to decision making Possible future developments Mark Williams, DG SANTE 1705 1725 Dealing with the (re)classification of active substances in the EU process Overview of classification issues How can industry respond to improve the system Additional options for future improvements Susy Brescia, UK 1725 1745 The regulatory challenges for industry The main focus areas and blockers in the regulatory process Requirements to improve the functioning of the legislation Active substance decision making medium term process improvements Martyn Griffiths, Bayer 1745 1830 Panel discussion 1830 1900 End of session 1; Drinks 1900 2000 Political discussion session 1900 1930 Political considerations for the future of crop protection in Europe Details tbc 1930 2000 Questions and answers with the floor 2000 Close 2000 Conference Dinner

March 10 th - Main Conference Le Plaza, Theatre 0830 1230 Session 2: Product authorisation issues 0830 0835 Introduction by the chair 0835 0900 Feedback from the Dublin Workshop & PAIG group Main conclusions of Dublin workshop Key follow-up issues and opportunities Main elements to improve the functioning of the zonal system Anne-Marie Dillon, Ireland 0900 0920 The zonal experience of the crop protection industry What progress has been made in improving implementation? Further areas for improvement in the process Dealing with Article 43 issues and options Kerry Gamble, Syngenta 0920 0940 Mission impossible: Early learning in managing Article 43 implementation A reminder of the provisions on Article 43 The current guidance to support the process Remaining issues for evaluators and some possible solutions Christian Prohaska, AGES 0940 1035 Discussion on Article 43 with representatives of the zones North Camilla Thorin, Swedish Chemicals Agency South Chara Panagopoulou, Greece 1035 1100 Coffee 1100 1120 Managing the legislative complexity to maintain product availability The key challenges of product availability RMS evaluation delays impact on concerned Member States Workable implementation of comparative assessment Guidance documents A help or a hindrance to the zonal system? Miriam Cavaco, Portugal 1120 1140 Managing the challenges in the zonal system: Key recent developments Efficacy national, zonal or EU approaches? How does comparative assessment fit in the system Maarten Trybou, Belgium 1140 1200 Evaluator view: Is industry adapting to the zonal system? The impact of the zonal system on industry submissions Submission quality are improvements possible? New challenges on the horizon that need to be considered. Pavel Minar, Czech Republic 1200 1250 Panel discussion with: Peter Schlotter, Dow Veronique Mironet, France

1250 1400 Lunch Le Plaza, Gallery 1400-1600 Session 3: Scientific developments: Guidance documents and Endocrine Disruptors 1400 1420 Overview of EFSA s work on opinions and guidance Recent opinions Focus areas for 2016-2017 Understanding the impact on harmonisation and workload Luc Mohimont, EFSA 1420 1445 Implementing scientific developments in Regulation 1107/2009 Commission role in scientific guidance document development Focus areas for current guidance development Status update on endocrine disruption criteria Karin Nienstedt, DG SANTE 1445 1510 Industry view: Evolving science and impact on testing programmes Opportunities to improve the focus of data and testing EU vs international developments Tox 21: An opportunity to shift the paradigm? Phil Botham, Syngenta 1510 1540 Panel discussion 1550 Conference conclusions 1600 Close