Agenda – Day III

Listed as a “leading authority” on EU Life Sciences law by Who’s Who Legal: Life Sciences 2015 Elisabethann Wright has been practising in the Life Sciences sector for over 30 years in both private practice and international institutions. Her role includes assisting clients in the classification of their products, the establishment of a pathway to authorisation and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals, data privacy obligations, and conduct of compliance and anti-bribery investigations.

Elisabethann Wright also has experience in litigation before the European Court of Justice, the European Court of First Instance, and the European Free Trade Agreement (EFTA) Court. Elisabethann was a R…f…rendaire (Law Clerk) at the Court of Justice of the European Communities for a number of years.

David Andersen is a Partner in our Risk Assurance Practice in London where he leads our team focusing on Governance, Risk and Compliance advisory and assurance services for the Pharmaceutical Sector. He also sits on the UK Governance, Risk & Compliance leadership team as the compliance subject matter expert. David’s Governance, Risk & Compliance experience includes: Design and management of regulatory compliance improvement programmes; Risk assessment and control framework design and implementation; Restructuring of global and regional governance and risk functions; designing and leading a global regulatory audit function; developing and deploying risk and control monitoring programmes for both clients internal operations and their 3rd party agents.

Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA’s General Management.

Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.

In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.

Roeland Van Aelst joined Johnson & Johnson in 1987 as a Medical Representative for Janssen Pharmaceutica. He held various positions of increasing responsibility in both sales and marketing and joined the Corporate Office of Health Care Compliance in May 2005 for the EMEA region with extension to Asia, Latin-America and Canada in 2008. In 2010 Roeland became responsible for EMEA & Canada cross sector. Since October 2012 he is the Regional Vice President – HCCO MD EMEA. Today he also fulfills the Chairman role of the MedTech Europe Ethics and Compliance Committee. He is a member of the board and a founding member of ETHICS, an association for Compliance professionals in the Health Care industry. Roeland is an active contributor to the Seton Hall/ Sience Poand the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.

Sofie Melis joined IFPMA in September 2016 and leads its Ethics and Compliance portfolio, which includes the global implementation and management of the IFPMA Code of Practice and the Ethics & Business Integrity Committee (eBIC). In her capacity, Sofie closely works with international stakeholders in building strategic partnerships that support public health goals worldwide. In the last 8 years of her career, Sofie has worked in corporate compliance for both Eli Lilly and Biogen Idec. Prior to that she held several roles in organisational learning & development in the banking, electronics and consulting industry. Just before joining the IFPMA, Sofie completed a one year assignment with the International Committee of the Red Cross as Head of HR Compliance. Sofie holds a master’s degree in Languages and Literature, a bachelor in Personnel Management, a post-master’s in Adult Education and a Certificate in International Compliance and Ethics.

Oscar Perdomo is a Director in PwC’s Pharmaceutical and Life Sciences practice with over 10 years of experience in the pharmaceutical and life sciences industry. Throughout his career Oscar has partnered with clients to deliver services related to strategy and business planning, business analytics, risk management, and project management.

Oscar has worked with many global pharmaceutical and life sciences companies to build and enhance their global compliance programs and to mitigate risks associated with interactions with healthcare professionals, anti-kickback laws, and anti-bribery / anti-corruption laws. In addition, Oscar has worked with clients to audit and monitor business activities, develop corrective action plans, draft and update policies and procedures, and train employees on global compliance issues and standards.