PCWP/HCWP info session on Antimicrobial Resistance 19 Sep 2017

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21 September 2017 EMA/478295/2017 Stakeholders and Communication Division PCWP/HCWP info session on Antimicrobial Resistance 19 Sep 2017 Juan Garcia Burgos Juan Garcia Burgos is Qualified Medical Doctor from the University of Autonoma in Madrid, specialised in urology. Juan worked as an urologist surgeon at the hospital Gregorio Maranon in Madrid. He joined the European Medicines Agency in 2002 in the scientific Units and was responsible for coordinating the preparation of EU clinical guidelines for drug development. He took up new responsibilities in 2005 where he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and HealthCare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences. In January 2017, he was appointed Head of Public Engagement Department and is Co-chair of the EMA patients and healthcare professionals working parties. Kaisa Immonen Kaisa Immonen holds a Master of Arts (MA) in international relations and conflict analysis from the University of Kent in the United Kingdom. She has eight years experience in European Union health policy gained firstly at the Thalassaemia International Federation, a rare-disease patient organisation in Nicosia, Cyprus and then with the European Patients Forum (EPF), in Brussels, Belgium. She has worked for EPF for six years and has served as director of policy since 2015. She is the co-chair of the EMA Patients and Consumers Working Party (HCPWP). Gonzalo Calvo Gonzalo Calvo is Past-Chair of the European Association for Clinical Pharmacology and Therapeutics (EACPT). He is a consultant in clinical pharmacology in Barcelona and has extensive experience both in medicines regulation, including nearly ten years as member of the Agency s Committee for Medicinal Products for Human Use (CHMP), and in learned societies. He is the co-chair of the EMA Healthcare Professionals Working Party (HCPWP). 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Martial Plantady Martial Plantady is a policy officer working in the Task Force on antimicrobial resistance (AMR) in the Directorate-General for Health and Food Safety of the European Commission. Graduated as a doctor in veterinary medicine with an additional Master degree in veterinary public health, Martial held different positions at the French Ministry of Agriculture from 1997 to 2006, dealing mainly with animal health issues, before joining the European Commission in 2007 where he worked on zoonosis control. He is charge of AMR issues since January 2016. Carmem Pessoa da Silva Dr Carmem L. PESSOA-SILVA, MD, PhD, is Brazilian, joined the World Health Organization (WHO) in 2005. From January 2005 to November 2011 Dr Pessoa-Silva was the Team Lead for the WHO programme Infection Prevention and Control in Health Care. In the context of renewed efforts to combat antimicrobial drug resistance, WHO established the Global Antimicrobial Resistance Surveillance System (GLASS) and appointed Dr Pessoa-Silva to lead the new programme. Prior to WHO, Dr Pessoa-Silva gathered 20 years of professional experience as an infectious diseases physician in Brazil where she is an Associate Professor of Medicine at the Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. Major WHO publications coordinated by Dr Pessoa-Silva include: Worldwide country situation analysis: response to antimicrobial resistance (April 2015). Global antimicrobial resistance surveillance system manual for early implementation (Sep 2015). Antimicrobial resistance: global report on surveillance 2014 (March 2014). WHO Guidelines: Infection prevention and control of epidemic- and pandemic-prone acute respiratory infections in health care (April 2014). Core components for infection prevention and control programmes (June 2008). She is also the author of several scientific papers, including (selected sample): Infection prevention and control of the Ebola outbreak in Liberia, 2014 2015: key challenges and successes. BMC Medicine, 2016. Moving forward in tackling antimicrobial resistance: WHO actions. Sex Transm Infect, 2013. The WHO policy package to combat antimicrobial resistance. Bull World Health Organ 2011. Reduction of health care associated infection risk in neonates by successful hand hygiene promotion. Pediatrics, 2007. Behavioural considerations for hand hygiene practices: the basic building blocks. J Hosp Infection, 2007. Control of community-associated methicillin-resistant Staphylococcus aureus in neonatology. J Hosp Infect, 2006. Epidemiology of endemic extended-spectrum beta-lactamase producing Klebsiella pneumoniae at an intensive care unit in Rio de Janeiro. Microb Drug Resist, 2006. Extended-spectrum beta-lactamase-producing Klebsiella pneumoniae in a Neonatal Intensive Care Unit: Outbreak Description and Risk Factors for Infection and Colonization. J Hosp Infection, 2003. EMA/478295/2017 Page 2/6

Mair Powell Mair Powell is a clinical assessor at the MHRA, member of IDWP (chair for 6 years in the past), member of SAWP and chair of VWP. Marco Cavaleri Marco Cavaleri is Head of Office, Anti-infectives and Vaccines in the Human Medicines Evaluation Division, responsible for scientific oversight and coordination of EMA activities for anti-infectives and vaccines. Marco Cavaleri is a Pharmacologist who spent several years in industry in R&D mainly in the area of anti-infectives covering different positions in preclinical and clinical development. In 2005 he joined the EMEA as Scientific Administrator in the Scientific Advice and Orphan Drugs Sector, specifically being in charge of anti-infectives and vaccines scientific advice procedures. He returned to the Agency in 2008 following a short period in industry leading clinical and preclinical development in the area of Gastroenterology and Infectious Diseases. He joined EMA in 2008 as Group Leader Anti-infectives in the Safety & Efficacy Sector, Pre-Authorisation Human Unit. In 2009 he was appointed as Head of Section for Anti-infectives and vaccines in the Safety & Efficacy Sector, Human Medicines Development and Evaluation Unit. Helen Jukes Helen Jukes is a veterinarian and after a period spent in clinical practice she joined the UK s regulatory agency for veterinary medicines, the Veterinary Medicines Directorate, in 2003. She has been the United Kingdom s representative at the CVMP since 2011 and is the chair of the CVMP s Antimicrobials Working Party. In this role she has also been a member of the Antimicrobials Expert Group (AMEG) and co-chair of the RONAFA, working groups which have provided advice to the European Commission on the use of antimicrobials in animals. Jordi Torren Edo Jordi Torren Edo, Head of Service of Veterinary Risk and Surveillance, Veterinary Medicines Department of the European Medicines Agency (EMA), UK. The department is comprised of the veterinary pharmacovigilance and antimicrobial resistance teams. Veterinarian, masters on regulatory affairs and pharmacology. Jordi Torren Edo is an expert on antimicrobial consumption in animals for the OIE and WHO. Herman Goossens Herman Goossens, MD, PhD, is a full professor of Medical Microbiology at the University of Antwerp in Belgium, chair of the research laboratory of medical microbiology at the University of Antwerp and director of the Laboratory of Clinical pathology of the University Hospital Antwerp. He received several honours and awards, including the American APUA (Alliance for the Prudent Use of Antibiotics). Herman Goossens published more than 600 publications (including one book, several chapters in books and review articles as well as editorials in leading journals) in international journals in the fields of medical microbiology and infectious diseases. He is the Founder Chair of the Belgian Antibiotic Policy Co-ordination Committee (BAPCOC). He was the Founding Coordinator of the European EMA/478295/2017 Page 3/6

Surveillance of Antibiotic Consumption (ESAC) project (moved to ECDC in July 2011). He currently coordinates several EC funded projects, such as the Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE), LAB-Net of the Combating Bacterial Resistance in Europe project (COMBACTE) and New Diagnostics for Infectious Diseases (ND4ID). He is the founder of the annual European Antibiotic Awareness Day (EAAD). Herman Goossens was elected chair of the Scientific Advisory Board of the Joint Programming Initiative on Antimicrobial Resistance by his peers. His professional goal is to bridge the gap between basic and clinical research, with a major focus on antibiotic resistance, to enhance the standard of healthcare, public health and professional standards, for the good of the public in large. He is a popular resource person and opinion leader, much sought after by local and international media for views on matters related to public health and infectious diseases. Giovanni Mancarella Giovanni Mancarella is the head of the Press, Media & Information team at the European Centre of Disease Prevention and Control (ECDC). He has been project manager of the European Antibiotic Awareness Day (EAAD) from 2011 to 2016. Currently, he coordinates the ECDC press team and keeps oversight of all communication activities related to the ECDC units, section as well disease programmes. In his current role, he also supports the European Commission and the Member States in the area of risk and crisis communication in the context of the Decision 1082/2013/EU on serious cross-border threats to health. Previously, he worked as a communication & policy officer for the Pharmaceutical Group of the European Union (PGEU) before joining ECDC in 2010. His academic background is in law, media and stakeholders relations, and languages. Andrea Nilsson Andrea Nilsson is a communication specialist, working closely with the European Centre of Disease Prevention and Control (ECDC) Antimicrobial Resistance & Healthcare-Associated Infections (ARHAI) programme since 2011. Besides her overall communication work with the programme, she is currently the project manager for European Antibiotic Awareness Day. Before joining ECDC in 2009, she worked at the press office of the French Embassy in Colombia and as languages teacher in several universities in the same country, where she is originally from. Her academic background is in journalism, media relations, communication and languages. Diane Ashiru-Oredope Dr Diane Ashiru-Oredope is the Lead Pharmacist for the Antimicrobial Resistance Programme at Public Health England A hospital antimicrobial pharmacist by background; she started working in public health in 2010. She has chaired and led the implementation of a range of national toolkits and guidance on antimicrobial stewardship. Diane led the development, implementation and evaluation of the national (now international) AMR campaign, Antibiotic Guardian which is underpinned by behavioural science. Currently she is the deputy chair for the English Surveillance Programme for Antimicrobial Utilisation and Resistance (ESPAUR) and Leads the national planning group for World Antibiotic Awareness Week, European Antibiotic Awareness Day and the UK Antibiotic Guardian campaign Outside of her core role, Diane is honorary Lecturer at UCL School of Pharmacy, volunteer tutor for the People s University which delivers public health Masters courses/modules for healthcare professionals in low and middle income countries, committee member for UKCPA Pharmacy Infection Network, EMA/478295/2017 Page 4/6

member of RPS Expert Advisory Group for Antimicrobial Resistance and adviser for Commonwealth Pharmacists Association.rah. In 2015 Diane was named Royal Pharmaceutical Society's Public Health Pharmacist of the year and in 2016 Outstanding Woman in the Public Sector at the 10th PRECIOUS awards. She was made a fellow of the Royal Pharmaceutical Society in 2017. Sascha Marschang Sascha Marschang joined the European Public Health Alliance (EPHA) in 2009. In 2017, he took up a new role as Director of Operations & Membership after working on the policy team for many years. He continues to co-lead EPHA s advocacy campaigns on antimicrobial resistance and on digital health and provides strategic support to the Secretary General and EPHA Board. He also represents EPHA on various stakeholder groups including the EMA s Patients and Consumers Working Party and the European Commission s ehealth Stakeholder Group. A dual German and Canadian citizen, Sascha worked at the Government of Ontario and completed a Master s degree at Toronto s York University before moving to Brussels ten years ago. Walter Marrocco Walter Marrocco is a family physician and is presently the representative of the European Forum for Primary Care in the HCPWP. Dr Marrocco is the Scientific Director of the Italian Federation of Family Doctors and President of the Italian Society of Preventive medicine and healthy life-styles. Dr Marrocco has been working with EMA to activate the interaction with GPs and has been instrumental, in collaboration with other representatives from the organisations representing GPs in Europe, in setting up the EMA s GPs expert group. Jamie Wilkinson Mr Wilkinson commenced his role as Pharmaceuticals and Professional Affairs Adviser of the PGEU in January 2014 before becoming Director of Professional Affairs in April 2015. The Pharmaceutical Group of the European Union (PGEU) is the European Association representing community pharmacists in 32 European countries. A pharmacist by training, he has practice experience in the community pharmacy sector and academia in the UK, in addition to experience in health policy, professional affairs and advocacy. He is a British national, was educated at the Universities of Kingston & St Georges London, holds an MSc in Social Research Methods from the University of Sussex and holds an MPH, Master of Public Health from the University of Sheffield. He is a Member of the Royal Pharmaceutical Society UK, a Fellow of the Royal Society for Public Health UK and a Practitioner Member of the Faculty of Public Health UK. In addition to English as mother tongue, Mr Wilkinson speaks French, elementary German and beginners Croatian. He lives in Leuven, enjoys motorsports and is a student private pilot. EMA/478295/2017 Page 5/6

Ber Oomen After having his diploma on the job trained general nurse in 1980 he specialized in mental health nursing for long term high care clinical setting. Currently he is unit leader of a ward for patients with severe mental conditions, Nijmegen Netherlands and responsible for overall patient and staff management. In 2003 he joined the Dutch association for psychiatric nursing as secretary and was co-founder of the European Association for Psychiatric Nurses in Europe. He fulfilled the role as secretary general in the organisation until 2009. In 2005 he took part in the first network meeting of the European Specialist Nurses Organisations accepted in 2008 the position of secretary. He reform the network into an European association based in Brussels and current executive secretary of the ESNO. In his position he is responsible for the overall management of the association, being proactive in expanding the network, advocating the role and position of the specialist nurse in the perused of recognition under the EU directive of professional qualification. He is active in a variety of health programs: Expert group health workforce of DG Sante, member of the European Policy Platform, Expert EMA health professional working party, participate in focus group in OECD on Skills mismatches, active on the bio-similar issue under DG Growth and EMA and Anti Microbic Resistance in EPHA and EMA. In ESNO he is project leader of the Switch Management Guideline for nurses. In addition he is also a strong promoter of Continuing Professional Development and Life Long Learning during nursing lifespan career, has a personal passion for creative thinking, generate opportunities, interconnect chances for others and loves outdoors activities in nature. Nationality: Netherlands Murat Akova Murat Akova, MD is a graduate of Istanbul University Medical School. He completed his residency training in internal medicine at Hacettepe University School of Medicine in Ankara in 1988 and in infectious diseases in 1991. Dr. Akova studied at the Department of Medical Microbiology in London Hospital Medical College, London, UK between 1988-1989 and obtained an DSc Degree in Clinical Microbiology from this institution. He was a visiting scientist at the Center for Adaptive Resistance and Microbiology in Tufts University School of Medicine, Boston, USA between 1992-1993. Currently, he serves as an attending physician in the Infectious Diseases Department at Hacettepe University School of Medicine. Dr. Akova is a member of the Executive Committee of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and his current function is the General Secretary and Scientific Affairs Officer. He is the president-elect of ESCMID from 2014-2016. Among his scientific research interests are infections in immunocompromised host and antimicrobial resistance. Pietro Stella Pietro Stella is working as scientific officer at the European Food Safety Authority, Unit on Biological Hazards and Contaminants. Originally from Italy, he is a veterinarian and worked for some years in the practice and in the meat sector. He joined EFSA in 2007 and since then he has been providing support to the Panel on Biological Hazards, coordinating its working groups dealing with topics related to food safety, microbiological risk assessment, TSEs and antimicrobial resistance. EMA/478295/2017 Page 6/6