Speakers & Moderator

Frédéric Broisse
Scientific Officer, EDQM, France

Frédéric Broise is a pharmacist. After more than 10 years working in the pharmaceutical industry mainly as a Quality Assurance Manager for Packaging, device and supply chain, he joined the European Directorate for the Quality of Medicines & HealthCare (EDQM) in July 2013 as eTACT project manager.

Brian Daleiden,
Vice President of Marketing, TraceLink Inc., USA

Brian leads global marketing at TraceLink. In this capacity, Brian also guides the company’s global regulatory analysis and market education programs that help industry stakeholders understand current and emerging regulatory, business and technical issues. In addition, Brian manages the TraceLink Cloud Community of thought leaders from across the global pharmaceutical supply network. Prior to co-founding TraceLink, Brian led product and corporate marketing at SupplyScape, a noted leader in supply chain security and integrity solution. In addition, Brian has held numerous marketing, business unit management and software development leadership roles focused on the global manufacturing and supply chain space at Catalyst International, Rockwell Automation and several startup companies.

Dr. Martin Friedrich
Bayer Technology Services, Leverkusen, Germany

Dr. Martin Friedrich, Diploma in Technical Cybernetics Univ. Stuttgart, PhD in Automation of chemical processes. Working for Bayer since 1992. Currently Head of Track&Trace with Bayer Technology Services, responsible for execution of coding & serialisation projects for pharma manufacturers. Project manager in EFPIA’s design and implementation of European medicines verification system since 2008.

Prof Dr Ulrike Holzgrabe
University of Würzburg, Würzburg, Germany

Ulrike Holzgrabe holds a chair in Pharmaceutical Chemistry at the University of Würzburg and is a member of several national an international committees dealing with the German and European Pharmacopoeia. Thus, she is interested in modern analytical methods for quality assurance of drugs.

Patrik Merckell
Global Program Manager Packaging Technology Strategy
Novatis Pharma AG, Basel, Switzerland

Patrik Merckell has worked for Novartis Pharma AG for eleven years in the areas of Packaging Technology, Product Security (Tamper Evident Packaging, Verification Features) and Artworks. He has a degree from the esig+ in Lausanne, the Swiss School for Engineers of the Graphical Industry.

Jesus Rivas
Novartis Pharma AG, Basel, Switzerland

Jesus joined Novartis in 2011 as Global Sourcing QA Manager after 9 years within the pharmaceutical industry where he has held different positions with increased responsibility in Qualification/Validation, Technical Support to Manufacturing Operations, and Quality Assurance where he worked as QA Responsible for Materials / Vendor Management and as Qualified Person (QP). He is pharmacist from Universidad Complutense de Madrid (UCM), Spain and holds post-graduate degree in Pharmaceutical Industry from CESIF Madrid, Spain. Jesus is also an active member of IPEC Europe being currently part of the GDP committee.

Lynda Scammell
Medicines and Healthcare products Regulatory Agency (MHRA), UK

Lynda works as the Senior Policy Adviser on the Enforcement Group of the Medicines and Healthcare products Regulatory Agency (MHRA).
The Enforcement Group within MHRA has powers to carry out investigations relating to crime involving medicines and bring criminal prosecutions through the Criminal courts. Lynda deals with all policy and legislative developments that affect the group and its operational activity and Lynda is the MHRA’s representative on the Council of Europe’s Counterfeit Medicines Expert Working Group (C-Med) and has been involved in training events / awareness raising initiatives in the EU, Eastern Europe and Africa. She part of the team responsible for the drafting of the Medicrime Convention from 2008 onwards.

Johannes Schön
Senior Manager Anti-Counterfeiting
Supply Network Quality Management
Boehringer Ingelheim GmbH & Co. KG

Johannes is responsible for Boehringer Ingelheim’s global anti-counterfeiting program covering aspects of response, monitor and prevention. He joined Boehringer Ingelheim in 2000 to head a QC laboratory for packaging materials and devices and a team performing validation and transfers of packaging processes. This was followed by assignments in BI’s global operations network and global supply chain including performance management and benchmarking. Since February 2012 he is in his current responsibility within BI’s Corporate Division Quality with a strong involvement in the global implementation of serialization.

Dr Stephan Schwarze
Bayer Pharma AG, Berlin, Germany

Stephan Schwarze is Head of Counterfeit Protection Management at Bayer HealthCare Pharmaceuticals.
In 2005 he started to establish and develop this function. Before he had worked in several different areas of R&D and production at increasing management levels. He is a member of EFPIA’s TEDOC Packaging & Distribution Subgroup. He had actively worked in WHO’s IMPACT Technology Subgroup and served several years as technical advisor to the Board of PSI. Furthermore he is engaged in the working groups at national (DIN) and European (CEN) level related to norming activities on “Tamper Verification Features” compliant with the EU Falsified Medicines Directive”.

Michael Wortmann
TAPA EMEA Board of Directors
Compass Transport Systeme
Düsseldorf, Germany

Michael Wortmann is working in international logistics and forwarding for more than 30 years. Since 1997, Michael holds management positions in the Düsseldorf based ComPass group ( a member of the dutch VCK group) currently as Managing Director of ComPass Transport Systeme. ComPass joined the TAPA association in 2003 and is TAPA certified since 2004. Michael was elected into the TAPA EMEA Board of Directors in early 2011. In this voluntary role, Michael is responsible as membership lead for all membership related affairs