Webinar:

Ensuring stability excellence for global consumer and OTC products

Sponsored by: Recipharm

Focused on:

  • OTC Products
  • Stability Testing

Date: 11 May

33

Time: 3PM London/10AM New York

Handling major stability programmes in different regulatory environments and categories

Stability testing is an essential step in the product development process, and a mandatory requirement in the life cycle of a treatment.

The International Council on Harmonisation - Quality (ICH Q1A) guidance exists to support companies in maintaining a rigorous approach to stability testing.

In this webinar, we will explore the detail of ICH Q1A and explain how to meet its requirements. We will:

1. Give an overview of stability requirements for different products such as OTC products, generic drug products, consumer health products

2. Explore the guidance for different dosage forms, such as: lozenges; topicals; parenterals; oral solids; and oral liquids

3. Explore current global regulatory requirements on stability testing by USFDA, ICH, EU, ANVISA and APAC

4. Explain the different stability testing approaches for drug products containing multiple APIs with different strength and SKUs

5. Share industry best practice and advise on data evaluation to accelerate stability study timelines

6. Recommend matrix approaches for reduced testing

7. Explore stability protocols and advise on how to set up studies and reporting

8. Advise on temperature cycling, freeze-thaw and shipping studies

Drug companies can ensure the success of their stability testing programme by working closely with partners who have specialist testing capabilities and study management experience. In our webinar, we will explore what to look out for when choosing a partner, from expertise in satisfying international regulatory criteria, to the capability to carry out real-time or accelerated testing to meet your needs.

In addition, a case study from a major stability programme will also be presented during the webinar, offering a real-world example of best-practice stability testing.

Presented by

Ramesh Jagadeesan,

Asst. Vice President, Analytical Development

Ramesh Jagadeesan, Ph.D in Pharmaceutical Analysis is currently heading the Analytical Centre of Excellence at Recipharm, Bangalore, India. He has 22 years of experience in analytical research and development. He has authored numerous research publications in the areas of analytical development, Analytical validation, controlled release technology and stability studies. He is an expert in stability studies for NCE, ANDA, commercial and clinical stability.

Maria Lundberg,

Vice President Product Development

Maria Lundberg is Vice President of Product Development at Recipharm. With 26 years in the pharmaceutical sector, including 15 years developing products for CDMO companies, Maria is responsible for leading Recipharm’s drug product development team, as well as heading up our formulation and analytical development operations globally. Prior to joining Recipharm, Maria worked across a range of pharmaceutical companies heading up the product development teams.

Aaron Small,

Vice President Global Development Sales

Aaron Small is Vice President Global Development Sales at Recipharm. He holds a BSBA degree in Marketing and a MBA and has been a part of Recipharm since 2011. During his time in Recipharm, he has contributed to business development activities for both development and manufacturing services. In addition, Aaron has been a part of brand development and deployment for the North American market.

Key Learning Objectives

  • Understand the different stability requirements for each drug product type
  • Learn about the critical stability requirements for your consumer healthcare products
  • Understand the key benefits of working with an expert stability study partner
  • Understand what needs to be considered to run a major stability programme successfully

Audience

  • Analytical services -Manager/Director/Head of/VP
  • CMC -Manager/Director/Head of/VP
  • Development - Manager/Director/Head of/VP
  • Formulation development -Manager/Director/Head of/VP
  • Pharmaceutical development -Manager/Director/Head of/VP
  • Chemistry/Medicinal Chemistry -Manager/Director/Head of/VP
  • Founder and CEO
  • Procurement -Manager/Director/Head of/VP
  • CSO
  • COO