64° Simposio AFI

The AFI Symposium is the important conference that has been involving stakeholders in the pharmaceutical industry internationally for more than 60 years, which is why it is confirmed year after year as an essential meeting and exchange moment between the protagonists of scientific research and companies.

AM is participating with the workshop:

Beyond compliance: strategies and innovation to meet the challenges of Annex 1.

Wednesday, June 11 - 10:00 a.m. - 12:30 p.m.

More than two years after the introduction of the new Annex 1, AM has observed a significant shift in the priorities of the life sciences sector. Companies are no longer just looking for quality products, but for integrated solutions and specialized advice capable of optimizing time, cost and performance while ensuring compliance with regulatory requirements.

Each production has unique critical issues that cannot be solved with standardized solutions. A tailored approach is needed, one that considers the many process variables and proposes targeted and effective solutions.

AM is offering an exclusive workshop where we will analyze some of the industry's most complex processes through real case studies, exploring strategies and innovations applied to effectively respond to regulatory challenges.

During the event, industry experts will share experiences and best practices to address two key issues:

• Contamination control in autoclave sterilization processes
• The qualification of biodecontamination activities in RABS facilities and pharmaceutical workshops

But that's not all. The workshop will also offer a perspective on AM's innovative solutions developed through experience alongside life science companies in the past two years.

A unique opportunity to engage with industry experts to gain practical knowledge and strategic updates.

HALL: Village Hall

MODERATOR: Lino Pontello - AFI Board of Directors.

10:00 - 10:10: Moderator's introduction

10:10 - 10:25: AM(Marco Bugliani - Marketing Manager AM ; Andrea Cenni Chief Sales Officer AM ): The consultative approach in supporting the life science market in adapting to new regulatory requirements

10:25 a.m. - 10:55 a.m.: GSK CASE STUDY (Alessia Gragnato - Microbiology Tech.Expert Quality Assurance GSK Manufactoring; Valentina Bianchi - Account Manager AM): Process of development and validation of products for packaging in Tyvek material

10:55 - 11:25: FARMIGEA CASE STUDY (Nicola Lucchesi - Qualified Person Farmigea; Giancarlo Traballi - Technical Services Coordinator AM). : Qualification of the biodecontamination process of a RABS through Zherox® b-pack.

11:25 a.m. - 11:55 a.m.: CASE STUDY PEDIATRIC HOSPITAL BAMBIN GESU' (Monica Gunetti - O.U. Qualified Person Head of Regulatory Affairs Pharmaceutical Workshop OPBG; Lavinia Monaco - Chief Sales Officer AM): Biodecontamination as a complementary approach to the management of downtime in advanced therapies

11:55 a.m. - 12:10 p.m.: AM (Maria Adele Imro Quality Assurance Manager AM - Annalisa Soldi Product Manager Contamination Control Solutions AM): innovation in the service of quality

12:10 - 12:30 Q&A

Link to registration