September 24-25, 2020, Rockville, MD
As Principal Scientific Affairs, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging.
Since 2015 Bettine is an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass).
Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She is active in the PDA Glass Handling Task Force and co-chairing the European PDA Interest Group Packaging Science as well as the Pharmacopeia Interest Group.
In 2015 she published the book "When Glass Meets Pharma".
She is a frequent speaker at industry conferences and has chaired and moderated several conferences for the PDA and other formats. This is adding to numerous trainings and publications that she has provided.
Dr. Boltres is a (bio)chemist by training, with a diploma in chemistry and a PhD in biochemistry.
Mrs Cathie Vielle graduated in Pharmacy in 1996 from the University of Strasbourg. Since 1996 she has held several positions in QA compliance and in supply chain departments in an international pharmaceutical company.
In September 2005, she became Head of Quality Department at a manufacturing site for worldwide markets (e.g. Europe, USA, Japan). She joined the EDQM in May 2009, as Head of the European Pharmacopoeia Department.
Erin Wang is an Associate Senior Consultant for Compendial Affairs at Eli Lilly and Company, USA. She is responsible for representing Eli Lilly and Company in global pharmacopeial related activities.
Erin received her B.S. degree from Tianjin University (China) in Material Science and Engineering, M.S. degree from Western Kentucky University (U.S.A.) in Analytical Chemistry. She was certified with U.S. Regulatory Affairs Certification in 2006.
Erin started her Lilly career as an analytical chemist for biotech API’s quality control. Subsequently, Erin managed analytical projects to support new product launch in the areas of purchased material and injectable product quality control.
Erin has been actively involved in U.S. PhRMA project team in developing ICH Q3D guideline for Elemental Impurities. She has been invited to speak at numerous global venues on a variety of compendial topics, including an emphasis on global pharmacopoeia harmonization and industry perspective for compendial requirements.
J. Mark Wiggins is Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years’ experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck & Co., Inc., (known as MSD outside the US and Canada), with more than 15 years’ experience submitting new and revised monographs to pharmacopoeias, as well as optimizing processes for review and response to proposed compendial changes from around the world. Mr. Wiggins has been an active participant in pharmaceutical industry associations in the US, UK, and Europe, and represented PhRMA on the ICH Q4B Expert Working Group to harmonize pharmacopoeia general chapters. Mr. Wiggins has published numerous papers, including an introduction to the concept of the "Ideal Pharmacopoeia," "Compendial Globalization," and the industry perspective on the pilot project for “Prospective Harmonization” of API monographs. He also co-authored a comprehensive series of twelve articles on pharmacopoeia compliance that were published as online regulatory sourcebooks. He has been an invited speaker at international meetings on compendial harmonization, including the Ph. Eur. workshop "Quality of Medicines in a Globalized World," and in discussions with pharmacopoeias and regulators in the US, UK, Europe, Japan, China, Korea, and India.