Propellant Change Of MDIs

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Course Overview

This course provides a practical understanding of data technologies used in clinical trials and is intended to provide attendees with the latest regulations, guidelines and requirements for using electronic data in clinical trials. With the recent widening of the guidelines and regulations to encompass electronic data, it is essential that all persons involved in any aspects of clinical trial data understand the principles and intent of the regulations. Companies must ensure that the QMS processes used in the management of clinical trials fully cover all areas of the regulations in relation to the management and integrity of clinical trial data.

This training course provides on overview of the key CMC aspects and regulatory requirements to be considered when reformulating pMDI products using alternative propellants. It will provide an insight into the inhalation drug product landscape, the relevant regulatory guidance documents, an overview of the alternative propellants and key aspects of formulation development of pMDIs. Furthermore, the course provides a deep insight into the critical quality attributes (CQAs) and specification settings for pulmonary drug products, followed by an overview of the requirements for demonstrating in vitro bioequivalence (IVBE) and drug product characterization and stability studies for the reformulated pMDI products.

Key Topics:

Inhalation Drug Products at a Glance

Relevant Regulatory Requirements

Overview of Alternative Propellants for MDIs

Key Aspects of Formulation and Process Development for MDIs

Key CQAs of Inhalation Drug Products – Performance Characteristics (DDU & APSD)

Specification Setting Based on Inhalation Drug Product CQAs

Requirements to Demonstrate Bioequivalence of Current and Reformulated MDIs

Drug Product Characterization and Stability Studies

Trainer Profile

Dr. Manfred Fischer

General Manager
Manfred Fischer Consulting

Dr. Manfred Fischer is a Biophysical Chemist. He has more than 30-year experience in the pharmaceutical industry, mainly in the CMC arena covering analytical / formulation development of new and generic products and Quality Control of medicinal products. He started his career in the pharmaceutical industry at AstraZeneca with a leadership role in analytical development. As the next steps in his professional journey, he served in several managerial and leadership roles in analytical development and quality control at AstraZeneca, AltanaPharma, and Eli Lilly. In 2007 Manfred Fischer joined Skyepharma (later acquired by Vectura), Switzerland as head of analytical development. In 2017 he became VP of pharmaceutical development of inhalation drug products at Vectura. He is the founder and General Manager of Manfred Fischer Consulting, a pharmaceutical company that focuses its consulting service on CMC aspects of analytical, formulation and device development.

Course Features

Real-Life Case

Courses with real-life case studies and best practices

Renowned Trainers

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Certificate

Certificate of completion issued by the trainer

Interactive sessions

Interactive sessions that go beyond traditional lectures

Benefits

Enhance the knowledge, skills, and competencies of your team in the Industry sector: Our curriculum is meticulously crafted to elevate your team's expertise in the industry, equipping them with the tools they need to excel.
Courses curated with real-life case studies: Dive into practical applications with our curated selection of real-life case studies, providing invaluable insights and hands-on learning experiences.
Certificate of attendance: Upon completion of the course, participants receive a certificate of attendance, validating their commitment to professional development and mastery of the subject matter.
Learn from well-reputed and experienced trainers with over 25 years of expertise: Benefit from the wealth of knowledge and experience offered by our esteemed trainers, each boasting over 25 years of industry experience.
Highly interactive and informative sessions: Engage in lively discussions, interactive exercises, and dynamic activities designed to enhance learning and retention. Our sessions are tailored to foster collaboration, critical thinking, and skill application.
Cost-effective yet result-oriented: We understand the importance of maximizing your training budget. That's why our courses offer exceptional value without compromising on quality. Achieve tangible results and measurable outcomes that drive success for your team and organization.

Course Price

Discounted Price €1,259

€1,399

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