Transparency4Safety - Protecting European Citizens

Europe stands at a critical crossroads. While citizens place their trust in safe and effective medicines, questions surrounding regulatory transparency, conflicts of interest, access to clinical data, pharmacovigilance and the independence of European regulatory processes continue to generate significant debate.

Across four sessions, participants will consider the evidence from regulatory classification and non-clinical assessment, through pharmaceutical quality and molecular characterisation, to post-authorisation safety data and the performance of European pharmacovigilance.

Bringing together scientists, clinicians, pharmacovigilance specialists and legal experts, the conference is designed for substantive exchange and detailed examination of the evidence.

The Questions Before Us

— Who truly decides which medicines are safe for European citizens: independent national authorities and elected representatives, or an under-scrutinised agency in Amsterdam heavily funded by the industry it regulates?

— How can Member States reclaim meaningful oversight when clinical data remains partially hidden, conflicts of interest persist, and conditional authorisations expand?

— What concrete reforms are needed to guarantee full transparency of trial data, real independence of experts, and timely detection of safety signals?

— How do we ensure that patient safety and democratic accountability are never subordinated to commercial pressure or centralised bureaucratic convenience?

Join us afterward for a cocktail reception!

AGENDA

10:00 Welcome and Opening Remarks

András László, President, Patriots for Europe Foundation; Member of the European Parliament (Fidesz)

10:15 Keynote Address

Gerald Hauser, Member of the European Parliament (FPÖ)

Why European citizens are entitled to see the evidence on which their medicines were authorised.

Online Contribution

Dr. med. vet. Helmut Sterz, toxicology; adequacy and representativeness of the nonclinical safety package (online)

10:30 Panel I – Regulatory and Legal Framework

This panel establishes the legal and regulatory frame for the day. It examines how mRNA and lipid nanoparticle products were classified within European pharmaceutical law, whether that classification was scientifically and legally appropriate to their biological mechanism, and what a possible misqualification would imply for the marketing-authorisation framework and for the expertise engaged in the assessment. The central question is whether the chosen regulatory category determined the level of drug-safety evaluation that was required, and therefore the depth of scrutiny these products actually received.

The session closes with open discussion with the audience.

Speakers:

Dr. iur. Silvia Behrendt, EU pharmaceutical law; marketing-authorisation framework; GHRA

Jun Ueda, PhD, international regulatory perspective; biological mechanism; Asilomar Initiative

11:45 Coffee Break

12:00 Panel II – Scientific Evidence: Product, Toxicology, Manufacturing and Quality

This panel will address the underlying scientific evidence, without legal contributions.

It turns to the medicinal product itself: the biological mechanism and the intracellular fate of modified mRNA; the non-clinical safety package and the adequacy and representativeness of the toxicological test substances; the structure, particle characteristics and formulation of the lipid nanoparticle; the manufacturing process from the material manufactured commercially, to comparability, release specifications and the validation status and limits of the analytical methods on which batch release and regulatory confidence rest. The governing question is whether the material that was tested adequately represented the material that was administered.

Speakers:

Prof. Dr. Andreas Schnepf, inorganic chemistry; product and LNP characterisation; Chemistry OPIR

Maria Gutschi, PharmD, EMA dossier synthesis Residual DNA and SV40

13:15 Lunch and Standing Buffet

14:30 Panel III – Long-Term Biological Safety

The panel sets out the scientific evidence first: what has been measured and by which methods, the limitations of qPCR, the difference between measuring drug substance and measuring the final formulated product, and what independent sequencing has established about plasmid and SV40-derived DNA.

It examines the regulatory dossier and the disclosure history, what was submitted to the authority and when, and what was assessed, before considering the scientific significance of these findings and their possible implications for long-term biological safety.

Speakers:

Maria Gutschi, PharmD, EMA dossier synthesis; Residual DNA and SV40

Dr. med. Michael Mörz, pathology and pathological findings relevant to post-authorisation safety

15:45 Coffee Break

16:00 Panel IV

Pharmacovigilance versus Real-World Evidence

The final panel sets the official pharmacovigilance system against real-world evidence. It examines periodic safety update reports, EudraVigilance and spontaneous reporting, the structural extent of underreporting, and batch-dependent safety observations together with the relationship between product quality and reported adverse-event patterns.

Speakers:

Jonathan Gilthorpe, batch-dependent differences in reported adverse events

Wouter Aukema, PSURs, EudraVigilance and signal detection

Franziska Meyer-Hesselbarth, regulatory action and patient safety

Jun Ueda, PhD, Asilomar, precaution and informed consent

17:10 Closing Remarks

MEP TBC

17:30 Cocktail Reception