End-to-End Regulatory CDMO Solutions: Development, Manufacturing, and Approval

Join us for a deep dive into the complexities of regulatory submissions, where we’ll explore key requirements and best practices for compiling, writing, and reviewing dossiers. Learn how Lonza’s Small Molecules team streamlines the process to ensure first-time compliance with technical and quality standards.

Register Free: https://www.pharmtech.com/pt_w/regulatory-cdmo-solutions

Event Overview:

In the complex process from development to commercial distribution, each phase poses its own challenges in terms of providing assurance of the safety, efficacy, and quality of the product being developed. Dossiers submitted to regulatory authorities need to include comprehensive data that meets the specific requirements of each authority, which is a complex task. This webinar will look at some of the requirements of the various health authorities. It will also describe how the Lonza Small Molecules team uses its extensive experience to assist in getting the filing right the first time, by compiling, writing and reviewing dossiers that meet all of the technical and quality requirements.

Key Learning Objectives:

• Get insights into the expectations of health authorities
• Discover the geographical spread and expertise of the Lonza team in multiple markets
• Find out how the team can work with you to address the common challenges in compiling dossiers

Who Should Attend:

• Regulatory and Compliance Experts: Regulatory Affairs Specialists/Managers, CMC Managers, and QA/QC Professionals
• Development and Supply Chain Experts: Pharmaceutical Formulation Scientists, Supply Chain Managers, and Project Managers in Drug Development
• Leaders and Partners: Outsourcing Managers for Contract Manufacturing, Academics/Researchers in Pharmaceutical Sciences, and Business Development Leads

Speakers:

Praveenkumar Devakadaksham
Director, Regulatory Affairs, CMC
Lonza Tampa LLC

Praveen started his career as chemist, and has worked in the pharmaceutical industry for more than 20 years, including site, corporate quality and compliance, and Regulatory Affairs leadership roles. He has experience in NDA and ANDA dossier preparation for both solid oral and parenteral formulation types, including radioactive and non-radioactive products. He has covered the technical side, and also business continuity strategy planning in acquisitions and divestment. During the Covid pandemic he was the point of contact from his organization (Sun Pharma) to communicate and engage with FDA’s Drug Shortage team to ensure supply of essential medicines from the company. Praveen has attended multiple FDA meetings representing the organization that he worked and various FDA conferences. He has a master’s degree in pharmaceutical sciences.


Roché Marcel Walliser, PhD
Director, Global Head Regulatory Affairs, Small Molecules
Lonza AG

Roché joined Lonza in 2016 as Chemist and Analytical Project Lead in the Quality Control QC-Launch Plant (LP) and Tides, Visp. The same year, he became Team Lead of the QC In-Process Laboratory in LP. From 2018 to 2020 he was Team Lead in Quality Control at Siegfried AG, Zofingen, Switzerland, before rejoining Lonza as Senior Specialist in the Regulatory Affairs Small Molecules Department in Basel. In 2022, he was promoted to Manager Regulatory Affairs Small Molecules, supporting several Small Molecules sites in Lonza’s global network. In 2024, was appointed as Director, Global Head of the Regulatory Affairs Team Small Molecules at Lonza, supporting five manufacturing sites across the globe. He holds a PhD in Chemistry from the University of Basel and EMPA (part of the ETH Zürich), Switzerland.

Register Free: https://www.pharmtech.com/pt_w/regulatory-cdmo-solutions