Reverse Engineering & PSD in Pharma MasterClass - EU edition

14-15 February, 2024

Bridging Technical Analysis with Management

This workshop provides an in-depth look into the nuances of reverse engineering and the preliminary stages of formulating pharmaceutical commodities.

14-15 February, 2024, Virtual

Time Zone: UTC/GMT+1 /CET

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Key learnings

Utilize

Utilize BCS Classification correctly and appreciate its importance for drug development

Execute

Execute pre formulation analyses, including Raman mapping and XRPD for investigating polymorphic forms

Apply

Apply knowledge gained in analyzing and developing generic pharmaceutical products.

Gain insights

Gain insights into the fundamentals and methodologies of reverse engineering within pharmaceutical innovation

Employ

Employ the BCS Classification effectively and recognize its relevance in the realm of pharmaceutical progression

Analyze

CraV and analyze Reverse Engineering Reports, recognizing their significance in developmental frameworks

Trusted by over 17,000 delegates across leading companies

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Pharma Online MasterClass

Overview

This workshop provides an in-depth look into the nuances of reverse engineering and the preliminary stages of formulating pharmaceutical commodities. The primary spotlight is cast on the detailed analysis of Active Pharmaceutical Ingredients (APIs) with areas encompassing API experimentation, particle morphology assessment, the phenomena of polymorphism, solubility profiles, and the nuances of BCS categorization.

#masterclass #glceurope #pharmaonlinetraining #globalleadingconferences #reverseengineering #psdinpharma

Trainer

Maria Sobusiak

Preformulation Projects Senior Specialist Pharmaceutical Works
Polpharma S.A.

Maria Sobusiak is a graduate of the Medical Chemistry at Adam Mickiewicz’s University of Poznań. Since 2016 Maria has worked at Pharmaceutical Works Polpharma S.A., where she started her career as Junior Analytical Specialist and reach in four years responsibilities of Preformulation Projects Senior Specialist. In Preformulation sections, she is responsible for leading specialized research and development work, focuses on the study of powder characteristics and particle size and shape assessment using laser diffraction methods having regard to different material properties. From 2019, Maria also delivers worldwide trainings, workshops and webinars for pharmaceutical industry on the topic of particle size analysis, performs as a guest expert of Malvern Panalytical and cooperates with the Medical University of Gdańsk delivers seminars for and workshops for students as preparation for the work in the industry.

Rafał Łunio

PhD, Research & Development (R&D) Director; Qualified Person (QP)
Polfa Tarchomin Pharmaceutical Works SA

Rafał Łunio is a graduate of the Faculty of Pharmacy at the Medical University of Gdańsk. His professional journey began as an academic teacher at the Department of Applied Pharmacy of the Gdańsk Medical University. At the same time, he conducted research as part of his doctoral work in collaboration with the pharmaceutical industry. After obtaining his Ph.D. in pharmaceutical sciences, he began working in the Research and Development Department at ZF Polpharma SA. Rafał’s professional career started from the position of a Specialist in preformulation and formulation, through to the Manager, and ultimately to the Head of the Global Department of R&D, also fulfilling the responsibilities of the R&D Director. The department led by Rafał was the global preformulation and scientific center for Polpharma Group companies. Currently, Rafał serves as the R&D Director and Qualified Person at Tarchomin Pharmaceutical Works. Rafał Łunio’s areas of specialization encompass research and development, preformulation, drug dosage form technology, and pharmaceutical analysis with elements of biopharmacy. He is also engaged in teaching, leading seminars, lectures, and practical sessions for pharmacists, representatives of the pharmaceutical industry, and pharmacy students.

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img RECOMMENDATION

Who should attend?

• Managers, Specialists, Researchers engaged in pharmaceutical research and development, particularly those focusing on reverse engineering, formulation development and preformulation as well as particle size characterization
• Scientists working on the characterization and analysis of Active Pharmaceutical Ingredients (APIs) and physicochemical studies
• Professionals handling the creation and interpretation of Reverse Engineering Reports within the context of development documentation.
• Individuals involved in any aspect of method changes and transfers within the regulated environment of the EU

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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10+

Years of experience

299

Events organized

3,410

Speakers

17,761

Attendees