Michael is a Managing Partner of Medidata’s Patient Cloud solution sales team, providing leadership and subject matter expertise in decentralized clinical trials and patient centric technologies. Over the last decade, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of decentralization technologies for hybrid and virtual clinical trials. He was involved in providing solutions for the first decentralized clinical trial with FDA oversight in 2011 as well as PCORI’s ADAPTABLE study with more than 15,000 patients, and many other fully decentralized and hybrid clinical trials. His 33-year career in medical research includes nearly a decade with the US government conducting and supporting surgical & preclinical research and more than two decades working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research. Michael is a decorated veteran of the United States Navy and resides in Brushy Creek, Texas where he is also an elected official serving his community.
Amer is currently the Managing Director of GxP Compliance and Training Partners (GCTP) founded to help pharmaceutical companies & academic institutions worldwide to achieve compliance with GCP, GVP, GCLP, GDP and GLP.
A clinical pharmacologist by education, he is a senior executive with 28 years’ experience within pre-clinical, clinical R&D and pharmacovigilance (PV) operations helping biotech and pharmaceutical companies worldwide to achieve compliance with GxPs (Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Vigilance Practice (GVP) and Good Distribution Practice (GDP)) Quality Assurance (QA).
Amer enjoys imparting his experiences through training provision and has, for over 25 years, been delivering training on GxP QA, clinical development/operations and Pharmacovigilance, as well as being an invited speaker at over 130 international congresses and as writer, published 2 reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. Earlier in his career, he was Assistant Editor for 11 medical journals and was the first invited Course Director for The Pharmacovigilance Auditing Course at the RQA.
Amer has over 21 years’ experience of directing and hosting Inspection Readiness Programs (Mock Inspections and Pre- / Post-Mock Inspection-Training).
His other previous positions include: Vice President GxP Quality Assurance, Compliance & Training at Karyopharm Therapeutics Inc. USA, Global Director, Head of Quality Assurance at Merck Serono, Switzerland, Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA where he conducted the first GCP-GVP inspection in the EU.
Katharina Lehmann is owner and president of the Lehman Group to which the companies Blumer-Lehmann AG, Lehmann Holzwerk AG and BL Silobau AG belong. Responsible for the strategic development of the companies, she already leads the Group in the fifth generation.
As a 24-year-old, while still studying business administration at the University of St. Gallen, she took over the family business, because at that time her father had to step short for health reasons. At the beginning she simply wanted to ensure the business would continue. Later on, she really liked her work and although entering the parental business was not part of her life plans, she decided to develop the great potential of the Lehmann Group. Katharina Lehmann has never regretted her decision. As an ambassador of the fascinating world of wood, especially for the extraordinary Free Form timber construction buildings, she has already travelled around the world. For 23 years now, she has now been at the head of the Lehmann Group, which under her leadership has greatly expanded its workforce, sales and business activities.
Alexandra is EBF’s Director of Cybersecurity & Innovation managing – in addition to cybersecurity – the Federation’s work on cloud, data, payments, virtual assets and AI. In the framework of cybersecurity and working closely with bank associations throughout Europe, she is responsible for the EBF cybersecurity strategy, positions on legislative/regulatory processes, relations with EU institutions, and projects aimed at the harmonization of the regulatory environment. An advocate of empowering bank employees and customers through cybersecurity awareness-raising, Alexandra is EBF’s liaison with Europol’s European Cybercrime Centre (EC3) in creating and promoting relevant campaigns. She is also a member of the Advisory Group on Financial Services of Europol EC3, the Expert Group on Finance Sector’s ICT Resilience & Security of ENISA, and the Working Group for Financial Services of ECSO. Moreover, she has represented the EBF on an ad hoc basis in projects of the International Banking Federation and the G7 Cyber Expert Group. Finally, she is responsible for the EBF Cybersecurity Conference, held in Brussels, every October in the context of the European Cybersecurity Month.
