PDA Manufacturing Meets Legislation Workshop 2024

Featured Presenters

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  Joachim Almdal

  Green Innovation Group

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  Joachim Almdal

  Green Innovation Group

  Joachim Almdal is a partner at Green Innovation Group, a management consulting firm specializing in sustainability within the life sciences and healthcare sectors. He has led numerous sustainability projects across the entire value chain, including maturity assessments of production sites, radical innovation with suppliers, and change management.

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  Bettine Boltres, PhD

  Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services

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  Bettine Boltres, PhD

  West Pharmaceutical Services

  As Director of Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This complements her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine has been an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and 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 was part of the PDA Glass Handling Task Force finalizing TR 87, is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, and is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances.
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  Marion Briggs

  Airfield Consulting

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  Marion Briggs

  Airfield Consulting

  Marion Briggs is a circular economy expert, and specialist in medical waste and materials recovery. She currently consults with pharma on initiatives around the regulation and recovery of injection waste for more circular and sustainable processing. She is also the previous Chair of the board of Friends of the Earth, Ireland and remains involved, which allows her to keep abreast of the wider sustainability movement.

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  Ursula Busse, PhD, MBA

  Head of Regulatory Affairs, Tigen Pharma

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  Ursula Busse, PhD, MBA

  Tigen Pharma

  Ursula is currently leading Regulatory Affairs for Tigen Pharma, a Swiss biotech company developing autologous T-cell therapies against cancer. Ursula joined Tigen from Boehringer-Ingelheim, where she was Head of Regulatory Intelligence & Policy. Prior to that, Ursula worked at Novartis as Global Head of Quality Intelligence & External Affairs, a role she assumed after a few years as Head of Project Office, Biopharmaceutical Operations, and Project Leader in CMC Regulatory Affairs for biotech products. Before joining Novartis in 2006, Ursula worked for startup biotech companies in Canada, in R&D, Quality Assurance and CMC Regulatory Affairs. Ursula can look back on over 20 years of volunteer engagement in several industry associations (PDA, DIA, ISPE, EFPIA) and served on PDA’s Board of Directors from 2012 to 2017. She holds a PhD in Cellular and Molecular Biology from Laval University (Québec, Canada), coupled with an MBA she earned with honours.
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  Oisin Daly

  GMP Inspector, EDQM

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  Oisin Daly

  EDQM

  Oisín Daly is a GMP Inspector at EDQM, Council of Europe, where he performs inspections of API manufacturing sites, mainly in Asia. Before this, he worked as a GMP Inspector with HPRA, Ireland, performing inspections of both finished dosage forms and API manufacturing sites. During his time working with regulatory authorities, he has been involved in multiple international working groups tasked with developing and revising GMP guidance. He has also previously worked in the pharmaceutical industry, in roles within the area of Manufacturing Science & Technology. He holds M.Sc. degrees in both Pharmacy and Data Analytics.

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  Dieter Hennecke

  Head of the Department Ecological Chemistry, Fraunhofer Institute Molecular Biology and Ecotoxicology

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  Dieter Hennecke

  Fraunhofer Institute Molecular Biology and Ecotoxicology

  Dr. Dieter Hennecke is since 2008 head of the Department „Ecological Chemistry“ at the Fraunhofer Institute for Molecular Biology and Ecotoxicology (Fraunhofer IME), Germany. He has a doctoral degree (1998) in chemistry and is an expert on the fate, degradation, and metabolism of organic chemicals in environmental matrices in the framework of the respective regulations (pesticides, pharmaceuticals, biocides, REACH). His expertise with 14C-radiolabelling as a means to investigate chemical degradation pathways in complex matrices is one of the key technologies used in this field. He uses it to develop and improve regulatory guidelines, e.g., a long-time member of national and international standardization boards (DIN, ISO).

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  Miriam Kremer van der Kamp

  Business Developer, Vils

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  Miriam Kremer van der Kamp

  Vils

  Miriam Kremer-van der Kamp holds a BSc in Engineering in Medical and Pharmaceutical Biotechnology from IMC Krems, Austria. She first gained practical experience working on the integration of VHP decontamination into an existing ceiling module for modular clean rooms. She is currently working as a Business Developer for Vils. Miriam joined PDA in 2022 and is now serving as the ECP Chair for the newly founded DACH Chapter. She was a poster presenter at her first Annual Meeting and is actively involved in promoting professional development and networking opportunities for emerging professionals in the pharmaceutical and biotechnological fields. Miriam is also contributing to organizing various events and initiatives to support the growth and engagement of the PDA community in the region.

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  Ana Kuschel, PhD

  Principal Scientific Affairs, West Pharmaceutical Services, Inc.

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  Ana Kuschel, PhD

  West Pharmaceutical Services, Inc.

  As Principal Scientific Affairs Europe, Ana is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This complements her previous role as Manager of Material Development, where she worked on both existing and new rubber formulations. Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups.
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  Louise Loughran

  Health & Safety Advisor, Eli Lilly and Company

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  Louise Loughran

  Eli Lilly and Company

  Louise holds a master’s degree in occupational Hygiene from the University of Aberdeen, and a postgraduate certificate in chemicals management from the University of Hull, UK. Louise has over 20 years of experience supporting Eli Lilly’s pharmaceutical manufacturing operations in Cork, Ireland. Currently, Louise leads the Lilly EU chemicals management program both at an operations and policy level. Through active participation in pharma chemical experts’ groups, Louise has helped form sector positioning on the revisions of various chemical legislation dossiers - REACH (Registration, Evaluation, Authorisation of Chemicals) and CLP (Classification, Labelling and Packaging) revision, which has been included in stakeholder responses to Commission consultations.  Louise regularly participates in Commission stakeholder consultation meetings as an EU Chemicals Expert on behalf of EFPIA, (European Federation of Pharmaceutical Industries Association).

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  Alexander Mitropoulos, PhD

  Director of Franchise Portfolio Management, MilliporeSigma

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  Alexander Mitropoulos, PhD

  MilliporeSigma

  Alexander Mitropoulos is the Director of Franchise Portfolio Management, PFAS focus at MilliporeSigma. He has acted as a Senior Product Manager and as a Senior Program Manager for Aseptic Filtration. He has over 14 years of experience in biotechnology and life science working as a researcher, principal investigator, and business manager. He received a B.S. and Ph.D. in Biomedical Engineering from Tufts University in 2010 and 2015 respectively and an MBA from the Isenberg School of Management – University of Massachusetts Amherst in 2024.

Presenters

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  Veronique Davoust, DPharm

  Pfizer, Inc.

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  Veronique Davoust, DPharm

  Pfizer, Inc.

  Véronique Davoust has over 20 years’ experience in the pharmaceutical industry, both in regulatory affairs and manufacturing, for Pfizer Inc. In her current position,she is responsible for the monitoring and analysis of European emerging regulations and guidelines, especially focusing on Good Manufacturing Practices and registration of the quality section of marketing authorization dossiers throughout the product life cycle, as well as on global topics such as serialization. Véronique ensures the communication and implementation of the guidelines and regulations within the firm, and the coordination of responses to proposed regulatory documents to the competent authorities.

  Véronique has been an active member of the PDA for more than 15 years. She was a member of the Board of Directors from 2007 to 2010, and co-chaired the PDA Paradigm Change in Manufacturing Operations (PCMO) project since its creation in 2008. She contributed to the PDA Technical Report No 54: Implementation of Quality Risk Management for Commercial and Biotech Manufacturing Operations.

  Véronique recently joined the PDA Regulatory Affairs and Quality Advisory Board and is a frequent lecturer at PDA conferences and meetings.

  Véronique is a pharmacist and earned a Doctorate in Pharmacy from the University of Rouen in Normandie, France.

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  Julian Petersen

  Head of Global Business Development Pharma, groninger & co. gmbh

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  Julian Petersen

  groninger & co. gmbh

  Julian is the Global Head of Business Development Pharma at groninger, a leading fill-finish equipment supplier headquartered in Crailsheim, Germany. Julian actively contributes to the industry as a member of the PDA SAB and co-leader of the PDA Sterile Processing Interest Group. Additionally, Julian is involved in several task force e.g., drafting Points to Consider (PtC) documents on Aseptic Filling and Restricted Access Barrier Systems (RABS). Julian’s industry contribution extends to being the President of the newly founded PDA D/A/CH Chapter. Furthermore, Julian is part of the planning committee of the PDA Annual Meeting and the latest PDA workshop on Manufacturing Meets Legislation. Julian also contributes actively to other industry initiatives in workshops and several speaking opportunities.
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  Stephan Rönninger, PhD

  Amgen Europe

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  Stephan Rönninger, PhD

  Amgen Europe

  Dr. Stephan Rönninger is the 'Head External Affairs Europe, International Quality' of Amgen. He provides leadership, support and represent of external activities impacting Amgen's operations functions. He works with associations in the EU, Japan and emerging markets with focus on Russia and Turkey. He is responsible for advocacy in various external organizations and provides assessment and communication to Amgen.

  Stephan Rönninger holds a PhD and an engineering degree in Organic Chemistry. After his postdoctoral studies, he worked for Roche 1992 - 2013, starting in an API manufacturing site with responsibilities for laboratory, project management, as production manager, in Quality Assurance and Quality Management. In 2003, he changed to the Roche Global Quality organization and was responsible for the Global Quality System of Roche and external collaborations.

  He represents Amgen in industry trade associations (e.g. EFPIA) and the European industry on GMP/GDP topics as well as at ICH working groups such as Quality Risk Management (ICH Q9), Quality Implementation Working Group (Q-IWG), and the GMP for APIs (ICH Q7) Implementation Working Group. In the Parenteral Drug Association (PDA), he is elected for the board of directors, past chair of the Regulatory Affairs and Quality Advisory Board (RAQAB), leader of the PDA-Europe Inspections Trends Interest group and co-chairs several international conferences and training events (e.g. with PIC/S). He is one of the founders and co-chair of the 'Paradigm Change in Manufacturing Operations' (PCMO) project in PDA.