Setting Drug Product Specification MasterClass - EU edition

06-08 October, 2025

Bridging Science, Compliance, and Patient Safety

Setting Drug Product Specification MasterClass - US edition

Move beyond regulatory checkboxes to mastering science-driven, globally compliant specifications that ensure drug product quality and patient safety.

06-08 October, 2025, Virtual
Time Zone: UTC/GMT+1 /CET

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Key learnings

Comprehensive Understanding

Master Regulatory and Pharmacopeial standards for drug substance and product specifications

Immediate Applicability

Develop and justify specifications across dosage forms oral, parenteral, topical, inhalation, and more

Acceptance Criteria Setting

Characterize and Control impurities and set clinically relevant dissolution specifications

Report writing skills

Write scientifically sound characterization of impurities and justification of specification reports

Trusted by over 17,000 delegates across leading companies

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Overview

In this Masterclass, youll move beyond regulatory checkboxes to mastering science-driven, globally compliant specifications that ensure drug product quality and patient safety. Regulatory scrutiny is increasing, and poorly justified specifications can lead to delays, rejections or worse recalls.

By the end of this Masterclass, you wont just know HOW to set specifications youll understand WHY they matter and how to use them to create a strategic advantage in regulatory submissions and product lifecycle management.

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Trainer

Pearl Pereira

As a dedicated professional with over two decades of experience, I am passionate about reading, engaging in constructive debates, and backing my claims with solid evidence, data, and logical arguments. This approach extends seamlessly into my work, where I excel in composing persuasive regulatory documents and addressing complex challenges.

My contributions have been recognized through awards such as the Xlerator and Integrated Product Development Star. These accolades acknowledge my proficiency in drafting scientifically sound justifications for regulatory deficiencies, harmonizing processes to reduce time, and fostering effective team-building.

Within my domain, I hold a prominent position as the go-to expert for technical issues related to analytical method development and specifications. My focus on key results and building a highly skilled team has yielded exceptional outcomes, while my constant learning allows me to adapt swiftly to emerging insights

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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 WHO SHOULD ATTEND

-Pharmaceutical Regulatory affairs professionals
-Analytical scientists
-Quality Control and Quality Assurance specialists
-CMC and Formulation development experts

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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