Archives: Speakers

For the past two years Nikolay has served as Project Manager responsible for the global implementation of BlueTeMS Project. Prior to this he was Quality Manager and Responsible Pharmacist of Merck Bulgaria. Nikolay joined Merck in June 2015 from Sopharma AD where he, over a five years period, held several positions in the manufacturing of dry-ice, aseptic and solid dosage products, validation of processes and equipment, validation of computerised systems, administration of electronic Quality Management System, motoring and coordination of all deviations, complaints, change controls, CAPAs, etc. Nikolay holds a master’s degree in pharmacy from Medical University of Sofia, Bulgaria.

Cécile Pascaretti holds a doctoral degree in Pharmacy from the University of Limoges, France. She is in Merck Healthcare for 22 years and was heading various quality positions locally in France and then globally covering GMP and GDP aspects. Cécile is in charge of the Supply Chain and Distribution Quality Management for Merck Healthcare. In this role, she is taking care of all the GDP topics especially external supplier management and qualification – validation. She is also Deputy Responsible Person for Merck Healthcare France.

Silvana Furfaro is currently the Head of Quality Assurance and Regulatory Affairs of Arrow Diagnostics SrL placed in Genoa, Italy.

Arrow Diagnostics is the Italian subsidiary of Seegene Inc, Seoul, Rep. of Korea, a worldwide leader of In Vitro Diagnostics products in the field of Virology, Microbiology, Oncology, and Anatomy Pathology.

Arrow Diagnostics is the exclusive importer of many important foreign companies in IVD field, and this company is also manufacturer of the IVD products branded AD4SEQ with NGS technology CE-IVD marked and currently ongoing under IVDr.

Silvana Furfaro is also Person Responsible for Regulatory Compliance for the reagents manufactured under AD4SEQ brand.

The company is certified ISO9001 and ISO13485:2016 with the ON BSI Netherlands.

In 2021, Arrow Diagnostics obtained the EU 2017/746 Regulation assessment, and submitted many Technical Files for the IVDr certification, that became official law last year, at May 26th 2022.

Being member of the Technical Committee of PharmacomItalia, she has a large experience in Molecular Biology and in pharmaceutical companies (more than 33 years).

In the past, Mrs. Furfaro worked in pharmaceutical companies as Manager of Quality Control, Quality Assurance, and Manufacturing Departments, improving her knowledge in GMP and GDP.

Mrs. Furfaro’ s main goal is to contribute at positioning Arrow Diagnostics as one the most important Italian manufacturers in the IVD field, in the next five years

Alan Kennedy is a specialist in supply chain dynamics who, with his extensive cross-sector experience, is focused on bringing best-collaboration practice to coldchain pharma-logistics. He is one of the principal architects behind the Poseidon program, a new logistics delivery model that has been conceived to radically transform the transportation of pharmaceutical products by sea. This is being achieved through the application of contemporary supply chain best-practice and structured, multi-party, collaboration.

Patrick is heading the Department Quality in Distribution, Artwork and Product Security @Merck since 2014. In this role he is deeply involved in all topics around distribution, warehousing, GDPs, validation and qualifications, risk assessment, etc. With his team he controls the worldwide shipments leaving all Merck manufacturing sites or CMOs. Before joining Merck Patrick was working as GMP and GDP inspector for the Austrian national Health Authority. Being responsible for international inspections he gained a lot of insights into the pharmaceutical world and quality practices of various pharma companies. As a member of the GDP drafting group at the European Health Authority EMA he was deeply involved in the generation and implementation of the EU GDP guideline. Patrick has also a broad knowledge in QC testing and product release as he worked in different QC labs for 11 years. He is a biotechnologist by training with a Master’s Degree of the University of Applied Science in Krems, Austria.

From my educational background I am biologist. I have completed my PhD at the Helmholtz Research Centre of Munich in cooperation with the Technical University of Munich in the field of toxicology.
After that I gained several years of experience in the pharmaceutical industry with a focus on quality management.
Since nearly 4 years, I am working within TÜV SÜD in the sector of Medical Health Services. Currently, I am leading a team of experts and auditors for non-active medical devices and I am responsible for the Article 117 business in the regions DACH & Nordics.
Besides these roles, I am Auditor and Senior Product Specialist for non-active medical devices.