Press Room

Webinar - Practical Management of Pharmaceutical Impurities

Start
Wednesday, July 15, 2020 - 16:00
End
Wednesday, July 15, 2020 - 17:00
Location: online
Drug Substance pharmaceutical industry | Hovione

Wednesday, July 15th, 2020  |  11 am (EDT) / 4 pm (BST) / 5 pm (CEST)

 

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Speakers

Marco Galésio - Analytical Chemist
Daniel Pereira - Analytical Chemist

 

The management and control of pharmaceutical impurities is a matter of great concern and is an important part of drug development and regulatory assessment. Current regulations and guidelines demand a comprehensive understanding of the impurity profile of pharmaceutical products, as their safety and quality can be impacted by the presence of impurities. The nature and the quantity of impurities is affected by different factors, including synthetic route of the drug substance, quality of the starting raw materials, reagents, solvents, excipients, packaging and storage of the final product.

The ICH quality guidelines ICH Q3A and Q3B address questions related to the regulation of impurities in the drug substance and drug product, whereas other ICH quality guidelines address specific types of impurities, such as residual solvents and genotoxic impurities.

With this webinar we pretend to look at the different sorts of impurities that may occur in pharmaceutical products and discuss current regulations, requirements and control strategies to be followed in order to comply with the current demands.

Learning objectives

  1. General pharmaceutical impurities management and control
  2. Control of Residual Solvent, ICH Q3C
  3. Control of Elemental Impurities, ICH Q3D
  4. Control of Genotoxic Impurities, ICH M7

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In an interview with Executiva, a portuguese media outlet focused on women´s leadership, Diane Villax, co-founder and long-standing leader of Hovione, reflects on her journey and the company’s development over more than six decades. Diane Villax’s career began at a time when few women worked outside the home. At 19, she joined a trading company as a foreign languages correspondent, where she developed essential business skills — including commercial correspondence, banking and export procedures — that later proved instrumental in helping her husband, Ivan Villax, establish Hovione in 1959. From its earliest days operating in the family home in Lisbon, Hovione adopted an international outlook. The company’s first major customers were in Japan, setting demanding quality standards that helped shape its long-term position in global markets. Over the following decades, Hovione expanded its footprint with the construction of its first manufacturing site in Loures (1969), followed by expansion to Macau (1986), the United States (New Jersey, early 2000s) and Ireland (Cork). The company grew into a global organization with more than 2,500 employees — including over 300 scientists — and a reputation as a preferred supplier to leading pharmaceutical companies worldwide. Throughout the interview, Diane highlights the values that have guided the company’s development: a commitment to excellence, a strong work ethic, and a focus on quality and long-term relationships. Although she did not have formal business training, she learned “on the job” and brought discipline, precision and structure to her role — particularly in the company’s early financial and administrative leadership. Now in her nineties and an active member of Hovione’s Board of Directors, Diane Villax remains engaged with the company’s evolution and governance, reflecting a continued commitment to its long-term development. Her story reflects entrepreneurial drive, resilience and long-term leadership — and offers insight into the values that have shaped Hovione’s trajectory for more than six decades. Read the full interview at Executiva.pt (in portuguese).    

Article

Hovione’s Diane Villax: “I was not brought up to be a business woman”

Feb 23, 2026