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Επιλεγμένο Μέλος ΚΕΜΕΛ

Όνομα: Κατερίνα
Επώνυμο: Παπαθωμά
Ιδιότητα: Consultant at MGC Consulting Services Former Medical Director Janssen EMEA, MID-SIZED Markets (MSM)
Ημ. Γέννησης: 1954-03-12
Μέλος του ΚΕΜΕΛ από: 2019
Καριέρα: Chemist of University of Athens, holding the Pharmaceutical Physician Diploma from the Basel University, Switzerland and having more than 30 years of working experience as Director of Medical, Scientific, Governmental & Regulatory Affairs and Health Care Compliance. Long experience in Corporate roles, leading international teams and EMEA (Europe, Middle East & Africa) and regional functions (2006-2018). Demonstrating an outstanding track record of integrity- based operation with proven ability to build trust amongst various internal & external stakeholders. Customer focused, results & performance oriented with innovative scientific approach & ability to adapt and change as needed. Working efficiently well across functions & groups (national, International, global), building effective collaboration and teaming. Excellent track record of people development Holding several JOHNSON & JOHNSON LEADERSHIP awards. International / Corporate Roles 2006-2007: Member of the Janssen HEALTH CARE COMPLIANCE COUNCIL EUROPE 2006-2009: PHARMACOVIGILANCE HEAD JANSSEN EMEA, SOUTH AREA (Spain, France, Italy, Portugal, Greece), Member of the EMEA PV & MEDICAL COMPLIANCE Leadership Team 2009-2010: HEAD & COORDINATOR of the Quality Management Systems (QMS) in LOCs of the ESEM Area (Europe, South East, Middle East) 2012-2015: Medical Director, JANSSEN GREECE- CYPRUS- MALTA 2015-2018: * Medical Director JANSSEN EMEA, MID-SIZED MARKETS (MSM) * Member of the MSM LT * Member of the EMEA MEDICAL AFFAIRS LEADERSHIP TEAM 2015-2016: EMEA MEDICAL AFFAIRS DISCLOSURE LEAD 2016-2018: JANSSEN EMEA MSL COUNCIL CHAIRPERSON, LEADER of the PHYSICIAN ENGAGEMENT EMEA INITIATIVE. Professional Membership and activities 2011-2017: President of the Hellenic Association of Pharmaceutical Physician (elected President for 6 consecutive years). Member of the International Federation of Pharmaceutical Physicians Member of the Drug Information Association Professional Experience CONSULTANT at MGC Consulting Services Jan 2019- today Fields of expertise: • Medical Affairs (Medical strategy & planning, organizational structure- MSL role, medical product strategy, medical operations) • Governmental Affairs (health policies & regulations at national, EU & European countries) • Regulatory & Health Care Compliance (policies, systems, audits) MEDICAL DIRECTOR JANSSEN EMEA, Mid-Sized Markets NOV 2015- DEC 2018 In this critical role I was driving Medical Affairs excellence across MSM countries (31countries in 10 clusters). I had the oversight and coordination of the respective local MAF functions. I was representing the MSM countries in the EMEA MAF Leadership Team and coordination RWE Initiatives with HEMAR and other functions. Also, I was acting as the MAF voice in the MSM Leadership Team JANSSEN EMEA MAF DISCLOSURE LEAD - NOV 2015- MAR 2017 Responsible to coordinate all the necessary plans & activities to ensure the smooth implementation of the DISCLOSURE of the HCPs transfers of value JANSSEN EMEA MSL COUNCIL CHAIRPERSON --MAR 2017- DEC 2018 My role was to lead the MSL Council which is a virtual group providing oversight and governance for the EMEA MSL Community (more than 400 MSLs). JANSSEN EMEA LEADER OF THE MAF “PHYSICIAN ENGAGEMENT” INITIATIVE- MAR 2017- DEC 2018 The objective of this initiative was to develop an industry leading MSL function across EMEA countries. MEDICAL DIRECTOR JANSSEN GREECE- CYPRUS- MALTA - 2010 - 2015 Responsible for the Medical Affairs functions, operations and activities in the entire cluster (clinical research, medical education, medical information dissemination, pharmacovigilance, medical and health care compliance). Same responsibilities for Cyprus and Malta clustered with Greece. MEDICAL DIRECTOR JANSSEN GREECE- JANSSEN ESEM QUALITY MANAGEMENT SYSTEM HEAD & COORDINATOR - JAN 2009- FEB 2010 In addition to my role as Medical Director (please refer above) I was leading the QMS function in the ESEM Area (Italy, Iberia countries, Turkey, Russia, New Europe and Balkan countries and Israel) with the objective to develop the quality system starting from Medical Affairs and Pharmacovigilance. All the local QMS Coordinators of the Area were reporting to me for this particular program MEDICAL DIRECTOR JANSSEN GREECE- JANSSEN HEAD OF PHARMACOVIGILANCE SOUTHERN EUROPEAN COUNTRIES- SEP 2006- JAN 2009: In addition to my role as Medical Director (please refer above) I assumed the responsibility to ensure pharmacovigilance compliance in this area. Also, until January 2008, I was responsible for the Regulatory Affairs, Pricing and Reimbursement Function. The same period (early 2008) Medical Department undertook the responsibility to organize and execute all the medical education programs for the Health Care Professionals. I continued my responsibilities to ensure compliance with Health Care Compliance Policies of J&J. MEDICAL DIRECTOR JANSSEN GREECE-JULY 1999- SEP 2006 leading the Medical Affairs Department (clinical research, medical information dissemination, pharmacovigilance, medical compliance). The same period, as mentioned above, Regulatory, Pricing and Reimbursement were reporting to me, as well. In Jan 2006 we finalized the Health Care Compliance Local Policies and I assumed the responsibility to ensure compliance according to those policies ROCHE HELLAS DRUG REGULATORY AFFAIRS DIRECTOR —-MARCH 1997- JULY 1999 responsible for products registration, pricing, reimbursement, pharmacovigilance, medical/regulatory clearance of promotional materials/ activities, scientific training and documentation. Also, I was acting as the Liaison for the Quality Assurance with FAMAR (local manufacturing & distribution). I was member of the European Regulatory and Pharmacovigilance Committee. CILAG/ JOHNSON&JOHNSON HELLAS & Janssen- Cilag SACI - OCT 1992- FEB 1997 Medical Affairs Manager- Director: leading the Medical Affairs Department (clinical research, medical information dissemination, pharmacovigilance, medical compliance) as regards the products owned by CILAG AG. The responsibilities were including the regulatory, pricing and reimbursement, again for the CILAG products. National Pharmaceutical Industry, National Institute of Pharmaceutical Research and National Medicines Organization NOV 1984- 0CT 1992: Head of R&D Department responsible for the development and execution of research programs for various products with the objective to be produced by the NPI. As regards the National Medicines Organization I assumed the role of the assessor of the products’ registration file in order to issue the marketing authorizations Sterling Drug Hellas - FEB 1977- SEP 1984 Quality Assurance & Registration Manager: responsible for the development, implementation and monitoring of the compliance with the quality assurance policies and procedures. Also, I was responsible for the registration procedures for the approval of the marketing authorization of the products. Professional Associations President of Hellenic Federation of Pharmaceutical Physicians (2011- 2016) Member of: · Swiss Association of Pharmaceutical Professionals · Drug Information Association · Greek Chemists Association · Greek Industrial Chemists Association · Greek Medicinal Chemistry Society
Ειδικότητα: Chemist, University of Athens, Pharmaceutical Physician Diploma, University of Basel
Σπουδές: Chemistry, University of Athens