We will be present at Pharmacy Expo 2025, taking place from May 27–29 in Warsaw, Poland. The event gathers key stakeholders from the pharmaceutical sectors to discuss current challenges, innovations, and regulatory developments.
Throughout the event, SciencePharma experts will contribute with dedicated lectures on key industry topics, providing practical insights for professionals working across development, manufacturing, and regulatory functions.
Lecture 1: Qualifying New Pharmaceutical Manufacturing Sites: Insights from Experience
Speaker: Jo Doucet
Day 1 – May 27 | 14:00–15:00
- Establishing and qualifying a new pharmaceutical manufacturing site involves complex regulatory, technical, and quality challenges
- This lecture offers practical insights based on real-world experience with site qualification in the EU and beyond. You will learn about key steps in the validation and qualification process, including GMP requirements and documentation expectations.
- The session will also cover strategies for planning inspections, ensuring compliance, and aligning qualification timelines with product launch goals. Ideal for professionals involved in manufacturing and quality assurance.
Lecture 2: Borderline Products and Their Diverse Regulatory Pathways
Speaker: Joanna Popiołkiewicz
Day 2 – May 28 | 12:00–13:00
This lecture will focus on so-called borderline products – those that are difficult to classify under a single regulatory category, as their properties, form, or intended use may overlap with several types of products.
We will explore the key differences between medicinal products, medical devices, food supplements, and cosmetics looking at legal definitions and the regulatory pathways that govern market authorization, documentation requirements, and manufacturer responsibilities.
You may learn:
- What are the core criteria for classifying each product group?
- What are the regulatory consequences of misclassification?
- How do European regulatory bodies approach borderline cases?
- How should we interpret ambiguous examples, such as medicinal creams, physiologically active supplements, or medical devices containing active substances?
The lecture is intended for professionals in regulatory affairs, R&D, and marketing, as well as anyone interested in the complexity of the EU regulatory framework for health and cosmetic products.
Lecture 3: Strategic Routes to Market: Key Differences Between CP, DCP, MRP, and National Registration Procedures for Medicinal Products
Speaker: Dagmara Sejdak
Day 3 – May 29 | 12:00–13:00
Planning to launch a new product in the European market? Choosing the right registration pathway can make or break your strategy.
- This lecture will guide you through the key differences between the Centralised, Decentralised, Mutual Recognition, and National Procedures – focusing on their legal frameworks, scope, and practical implications.
- You will learn when each procedure is applicable, how product type and target markets influence the choice, and what timelines, costs, and documentation requirements to expect.
- The session will also cover strategic considerations for expanding existing marketing authorizations and highlight common challenges to avoid pitfalls while navigating the complex EU regulatory landscape.
Visit SciencePharma at Booth D3.09a
You are welcome to visit us at Booth D3.09a throughout the event. Our team will be available for discussions, questions, and informal consultations. We invite you to stop by and connect with us during Pharmacy Expo 2025.