now and then

Curriculum Vitae

Updated: September 2024

AMPHARCO (Amoureus Pharma Consulting)

Consultant/Owner: Free-lance/interim QP/RP/DP, pharmaceutical regulatory and quality consulting.

Projects/assignments

08/2024 – present: Netherlands based pharma company: QP (importation), QMS enhancement, API-Registration project (envisaged Designated Person), advisory to business development projects.

10/2023 – present: Netherlands based pharma company: (project) RP, facility changes, QMS to next level, implementation of electronic quality management system, preparation for and follow-up of GDP inspections, supplier audits, advisory to business development projects, API-Registration project, Medicines without Marketing Authorization project; interim QA Manager (maternity leave).

08/2023 – present: Netherlands based start-up pharma company: co-authoring of required GDP quality system, WDA application project, preparation for GDP inspection, follow-up of GDP inspection, contract wholesaler audit; contract-RP from issue date of WDA, advisory to business development projects; QP-RIP (Belgium).

07/2022 – 11/2022: Netherlands based start-up pharma company: set-up of required GDP quality system.

11/2021 – 08/2024: Netherlands based pharma production company of pharmaceutical ingredients, mixes of ingredients, intermediates for medicinal products, kits with ready-to-use pharmaceutical products: interim QA Manager/QP/RP/DP; revised quality system, introduced pragmatic lean approaches in handling of critical aspects in quality, increased quality awareness, started implementation of electronic quality system, secured renewal of GMP and GDP/GDP-API certifications, mentored QP-trainee and on-boarding of new permanent QA Manager; quality management of (product) development projects. Change-over of part of portfolio to food products: set-up and integration of pharma and food regulated SOPs, preparation for organic (“BIO”) certification inspection and FSCC 22000 audits.

10/2021 – 03/2022: Netherlands based pharma company: lead in set-up of development programme for production and control of oral solution (human medicine, worldwide marketing, rare diseases), from quality and regulatory perspective.

10/2021 – present: short-term consulting contacts in regulatory and quality field, various companies/persons

NordMedica A/S

Denmark based pharmaceutical company acquired by Eurocept Pharmaceuticals Holding, early 2013. One product (hemato-oncology) with marketing authorizations in 8 EU countries and supply on Named Patient basis in 12 countries worldwide. Global potential. Following acquisition, all pharma (operational) activities transferred to Eurocept International, leaving NordMedica as financial vehicle.

Integration of all Pharmaceutical and Medical Affairs activities in Eurocept corporate function. Brought regulatory, production and quality processes up to standard. Preparation and management of 10+ EU country DCP procedure and National Procedure in Switzerland. Re-designed product formulation and entire chain of production with new CMOs. Management of relevant Pricing & Reimbursement procedures for market access or price adaptation to European pricing strategy.

Eurocept (International) BV / Lucane Pharma SA

Independent privately owned group of pharmaceutical companies under Eurocept Pharmaceuticals Holding. Netherlands head-quartered and based. Strong growth and global territory expansion.

Searched on basis of function profile defined by local growth and European developments. Important pharmaceutical marketing areas: anesthesia, urology, anti-infectives, oncology, rare metabolic diseases. Mix of wholly-owned and in-licenced products. Medicinal products as well as medical devices. In 2009-2017 period, functional responsibilities extended also to Eurocept’s medical homecare companies providing home care patient programmes for all major pharmaceutical companies in the Netherlands and distributing a wide range of different medical products (since 2017 under Eurocept Homecare Holding and legally and operationally separated from Eurocept Pharmaceuticals Holding). In 2017, Eurocept Pharmaceuticals Holding acquired Paris based Lucane Pharma, as part of a strategic growth plan.

Initially, responsible for all Pharmaceutical and Medical Affairs (regulatory affairs, pharmacovigilance, (contract) production, quality (GMP, GDP, quality of care), medical information, medical affairs, pricing & reimbursement). From 2017 and with development of company, focus on (corporate) production, quality & compliance. Member of Leadership Team. Qualified Person (GMP), Responsible Person (GDP), Designated Person (GDP-API), and until, July 2019, EU Qualified Person (PV). Direct and indirect responsibility for 20 functional staff. Product portfolio includes over 100 medicinal product marketing authorizations, globally. Brought regulatory processes and dossiers up to standard. Introduced pharmacovigilance at current standard. Introduced quality processes and SOP management system to cover all group processes in GMP, GDP, PV, and areas of promotion. Introduced lean supply chain for marketed medicinal product, including harmonization of specifications for multi-market product. Introduced supplier management covering 15 CMOs. Brought warehousing and distribution up to current GDP standard. Managed Pricing & Reimbursement processes in several European countries. Provided oversight to API and Finished Product production development. Implemented new warehousing (and production) management system. Implemented in-house facility for secondary packaging. Implemented serialization processes and designed lean and cost-effective serialized portfolio. Transferred and integrated pharmaceutical operational activities of Paris based Lucane Pharma into Eurocept International, leaving Lucane Pharma in Paris as Distributor (“Exploitant”) for France. Responsible for development of 5 new formulations of existing and new product. Delivered (technical) expertise in recent CP-processes in EU and regulatory processes run by partner companies in countries outside EU.

Pfizer BV

Netherlands affiliate of Pfizer Inc., Pfizer Worldwide Pharmaceuticals Operations group, developing, producing and selling pharmaceutical products.

Searched on basis of function profile defined by local growth and European developments. Marketing areas: cardiovascular, metabolism, CNS, pain, anti-infectives, women’s & men’s health, respiratory, urology, oncology, and more to come.

Responsible for Regulatory Affairs (for 5 years Pharmacovigilance included) in broadest sense, as part of Medical Department, within Netherlands marketing company (“account manager” towards Netherlands Regulatory Authorities). Focus on compliance and marketing support. Qualified Person (GMP + GDP). Member of Medical Department management. Member of various (international) cross functional (project) teams. Senior role in European Regulatory Affairs organization (process development, piloting, dealing with medical devices). Member of European Regulatory Strategy Group (advising global leadership: clinical development, registration paths, rapporteurships, new therapeutic areas, labeling upgrades, referrals). During 5 years Chairman of Nefarma (Trade Association) Pharmaceutical Affairs Sub-Committee.

Direct responsibility for 6 functional staff. Accomplished integration of RA groups in two mergers: people, processes, dossiers, archives, etc. Product portfolio included over 200 registrations (CP, MRP, National). Achieved portfolio rationalization with 30% reduced workload. Created (international) processes & practices to show one face towards authorities. Brought over 50 neglected dossiers up to date and in compliance. Initiated (electronic) document management and information sharing. Leading role in cross functional processes: reimbursement, regulatory compliance and logistics, clinical trial applications, compassionate use, risk management. Intermediate in European registration processes where Netherlands authorities are leading (2x RMS incl. referrals, 6x (Co)Rapporteur, and more). Co-Lead in Scientific Advice and Pre-Submission meetings with Dutch authorities (5-10x year). Lead country in implementation of (Global) regulatory document management system.

NPBI International BV

Since January 1998, part of German Fresenius AG companies, with great deal of independency. Its business was to develop, produce and sell medical/pharmaceutical products.

Searched to help expanding the Product Partnering department of the Hospital Products Business Unit. NPBI then had 2 business units: transfusion products and hospital products.

Responsible for initiating, maintaining and expanding the relationship with Product Partners of NPBI (i.e. internationally operating pharmaceutical companies including renowned multinationals for which NPBI developed and produced parenteral specialties), coordinating all contacts from NPBI with the Product Partner and vice versa, jointly making strategical plans, implementing these plans and accomplishing set targets.

Responsibility for 3 starting and 6 existing accounts. Defined acquisition plan and started implementation. Adjusted marketing approach towards today’s views. Contributed to e.g. quality organization with knowledge and experience (registrations, audits, quality system).

Euro-Baby / Abi-Plus group

A family-owned group of enterprises developing and selling furniture and furnishings. Then market-leader in Holland for interior decoration of nurseries/children rooms, impressive penetration in other European countries.

Invited by father-in-law, then President-Owner, to build a proper organization to better address the explosive growth and develop export activities.

Started to re-structure logistic and financial processes. Introduced Human Resources function and upgraded personel quality level. Introduced elementary marketing principles for modern business planning and market approach. With outside consultants’ help, turned around financial administration and information systems. Prepared merger of original Euro-Baby BV and Abi-Plus BV. Laid basis for impressive export growth. Export ratio of overall turn-over 1991: 8%, 1996: 35%. Prepared start-up of two sister companies. Final position, Export Manager (Associate Director) for three companies with responsibility for further channeling and expanding export activities.

MediSense Europe BV

MediSense Europe BV was the coordinative European sales and marketing organization for MediSense Inc., a USA high-tech company developing, producing and selling biosensor diagnostics.

Invited to assist building the European marketing and sales organization. In 1992, this organization comprised a head office with 4 central departments (marketing, finance & administration, human resources, regulatory affairs/quality assurance) and sales organizations in 12 countries. In the South and East of Europe, sales were through distributors.

As Director RA/QA, responsible for all aspects of product registration (“market approval”), product reimbursement and product listing as well as for all aspects of quality assurance inherent to international distribution. Also responsible for European logistics and for office management. Operational responsibility during start-up of sales activities by MediSense in the Netherlands. European management team member.

Product registrations accomplished in accordance with regulations for medicines, medical devices and/or in-vitro diagnostics. Technical support in product reimbursement and product listing procedures. Drafting, review and approval of product labeling, data sheets, technical files, promotional materials. Regulatory support to product development and marketing activities. Defined and implemented a quality system for warehousing, distribution, sales and after-sales services. Set up a European logistics system; product inventory management, sales statistics, product configuration analysis, sales forecasting, planning and control of product supply and production. Management of product supply to distributors.

Baxter BV

Baxter BV (previously named Travenol BV) is the Dutch subsidiary of Baxter Inc., a USA company developing, producing and selling medical products.

Appointed to assist expanding the Dutch sales organization. In 1989, this organization comprised 5 business units: blood and blood therapy products, renal therapy products, cardiovascular products, diagnostic products, and general hospital products.

Pertinent to the Medicines’ Act, Regulatory Affairs Manager and Responsible Pharmacist with responsibility for all aspects of product and establishment licensing inherent to a Dutch importer and distributor organization. While RA/QA Manager and Responsible Pharmacist, responsibilities were extended to cover the entire product range, thus meeting expanding regulations. Also responsible for quality management in a sales and distribution organization. Responsible for packing and labeling operations with regard to sterile medical devices. A leading role within the European Regulatory Affairs group. Lastly, responsible for Regulatory Affairs throughout the Benelux. Member of management committee.

Accomplished product registrations and establishment licensing in accordance with regulations for medicines, biologicals and medical devices. Proposed, defended and approved specifications of product and its manufacture for the Dutch market. Drafted, reviewed and approved texts for product labeling, packaging, directions inserts, brochures, data sheets etc. Provided technical support to tender submissions and contract sales. Gave regulatory and pharmaceutical professional support in product development and sales activities. Jointly defined and implemented a quality system for warehousing, distribution and sales. Set up a release and production control system for pharmaceuticals. Participated in government working groups on medical products legislation.

Royal Dutch Army, Central Military Pharmacy

Military service spent in the Central Military Pharmacy, then central institution of the Royal Dutch Army for production and quality control of purchased and/or in-house prepared medicines and other medical products, and dispensing thereof.

As Deputy Chief of production and Deputy Chief of Quality Control, revised procedures of production to meet GMP requirements. Also revised procedures for quality control and product purchase requirements on basis of newly introduced regulations for sterile medical devices. Co-initiated commercial-company-type management of production and quality control.