Development of generics: From R&D to GMP MasterClass - EU edition

27-30 January, 2025

Paving the Way from Development to Lifecycle Management

The training aims to generate a common understanding of how to best interlink two areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products.

27-30 January, 2025, Virtual

Time Zone : UTC/GMT+1 /CET

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Key learnings

Understand

Understand how Generics, Hybrid drug products, Biosimilars, and WEU products are defined in the EU and U.S. legislation

How

How can development candidates for these product categories be defined based on already marketed target products as well as considering data exclusivity and IP protection of competitors in both regions?

Concept

Understand how Quality by Design development can be implemented and a robust GMP fundament can be created without creating unnecessary administrative hurdles

Clinical Study

Clinical study concepts for Generics, Hybrid Products and Biosimilars: planning and execution of studies.

Biowaiver concept

How can the number of studies be limited by the application of the Biowaiver concept?

CTD section

Different approaches in the EU and the U.S. for CTD section 3.2.R

Trusted by over 17,000 delegates across leading companies

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Overview

The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environment and the functional priorities is a key success factor. R&D needs flexibility and should not be overregulated, whereas GMP concentrates on standardization and high throughput. On the other hand, R&D has to create a solid and robust fundament to enable manufacturing and quality control units to work according to established and efficient procedures. Product development has become even more challenging with an increasingly globalized approach of the Generics Industry which earlier was focused on national or regional markets. Today, a global perspective is business-critical to stay competitive. This global perspective has impact on the development process, starting with global sourcing of the API. Understanding the different legal environment and eventual different properties of the reference product is a key success factor for global Generic drug development. This should be considered during the entire life cycle of the drug product. The training aims to generate a common understanding of how to best interlink the R&D and GMP areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products. Furthermore, specific challenges related to pharmaceutical development in both regions EU and U.S.- will be discussed.

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Trainer

Dr. Helmut Vigenschow

Senior Consultant
ViPharmaService

Dr. Helmut Vigenschow, Senior pharmaceutical consultant and founder of ViPharmaService.

During more than 30 years of professional experience in the pharmaceutical industry, Helmut held senior positions in QC, Project Management, regulatory affairs, Pharmaceutical Development and Quality Assurance. He worked for 3 years in India to set up a pharmaceutical development center for ratiopharm GmbH as a greenfield project. Since 2016 he is supporting the pharmaceutical industry as an independent consultant in the areas of Drug Regulatory Affairs, Quality Assurance, and as QP. Due to his in-depth experience in R&D as well as the GMP area, he perfectly knows the challenges and opportunities at the interface between these fields. He has supported several companies with development projects for APIs and drug products. Additionally, he acted as a visiting lecturer at different universities teaching Drug Regulatory Affairs.

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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?

Heads of R&D

Manufacturing Heads

Heads of QC

Heads of QA

Pharmaceutical Development managers

Manufacturing managers

Stability control managers

QC managers

Drug Regulatory Affairs managers

Product Maintenance managers

Ticket options for you

Full event
pass

Team participation?

*minimum of 10 participants

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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 its 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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