Helma Frasa Email & Phone Number

Den Haag, The Netherlands

Ede

Responsible for site QESH, to further strengthen QA/QC and safety (EHS) at NIZO.

Zeist, The Netherlands

Leading the department conducting Immunology and Toxicology research GLP studies. I have three direct reports (teamleaders) and 65 indirect reports. Responsible for Operational Excellence (Lean) and high GLP and scientific quality of immunology and toxicology research in our GLP test facility.

Utrecht Area, Netherlands

Heading the Program Management Immunology Department with focus on viral infections (vaccines), cancer immunotherapy (oncology), and autoimmunity. Find together with Pharma and Biotech companies solutions for their research questions in the area of viral infections, cancer immunotherapy and autoimmunity.

Haarlem Area, Netherlands

Lead the site's Innovative Quality Control (QC) laboratory team (15 FTE) in establishing and maintaining GMP quality in accordance with Site SOP’s, regulatory guidelines and GMP compliance requirements.Maintain high standards of GMP quality through managing and continuously improving the effectiveness of laboratory quality processes and systems.Method development & validationo Ensure method development, verification and GMP validations according local, global and regulatory guidelineso Ensure the support of stability studies as well as process and cleaning validationso Manage validation of methods and equipmento Assure analytical methods are in accordance with regulatory compliance USP / Ph. Eur / JP/EMA and registration files TransfersEnsure product transfers across sites also include the transfer of quality information (knowledge, documentation, processes, etc.), analytical method transfers;o Successful transfer of two projects (7-10 UPLC/HPLC analytical assays each project) from Teva R&D sites from (Gödöllő, Zagreb) to TEVA Pharmachemie in Haarlem;o GMP, responsible for safety (EHS) of the three QC laboratoryo Contributed to the data integrity awareness trainingo Successfully passed global TEVA ENHESA audito Successfully passed Brasil ANVISA regulatory audit

Leiden, The Netherlands

HAL Allergy develops and markets innovative products, that are convenient-to-use, for the treatment of respiratory, venom and food allergies.Heading the GMP compliant Quality Control department of 25 people.>Responsible for Biochemistry and Microbiology quality testing, for the release of marketed products and R&D samples.>GMP Stabiliy testing program and on-going stability testing, stability report writing>Assay validation>Environmental monitoring, sterility, endotoxin, and bioburden testing>Successfully passed GMP inspection (IGZ)>Stability reports were generated under time pressure to be able to timely update regulatory dossiers for the 6 major sublivac allergen therapeutics for the German market. To fulfill the requirements of the regulation of Therapy Allergens in Germany;>Reduced the number of delayed GMP batches, once to zero;>Appointed an QC analyst to QC Officer (to solve GMP deviations, OOS, initiate CAPA and change controls);>Raw material sampling & testing.

Amsterdam Area, Netherlands

>Responsible for approx. 30 FTE. Responsible for sampling and testing a wide range of materials including raw materials, in-process samples, drug substance, drug product samples, stability samples and environmental monitoring samples.>Responsible for three main units: Analytical (bio)chemistry, Microbiology and Analytical Development & Validation>Responsible for Environmental (EM)& Utility Monitoring (UM)>Leading Quality Control Compliance Improvement Projects >Wrote and led major QC improvement plan driven by global regulatory compliance (e.g. GMP, ICH, and FDA)-75% realized in 2013;> Increased batch release in time from 90% (Q3) to 95% (Q4) and decreased (25%) number of deviations;

Woerden, The Netherlands

The Alfasan Group is a Dutch family company that has been active for over 35 years in development, registration, manufacturing and marketing of veterinary medicines. It consists of 4 BV’s: Alfasan Nederland BV, Alfasan Diergeneesmiddelen BV, Alfasan International BV, and Alcomed BV, the own GMP-certified production facility.Lead the Regulatory Affairs Department at Alfasan; Regulatory Affairs Managers, Regulatory Affairs Officers and employees of the Regulatory Affairs Department internally and externally. Also responsible for outsourcing clinical bioequivalence studies and European DCP and MRP projects.Results:• Registration of Euthanimal 40% and 2 variations in European DCP in 21 countries for Ceftiosan• Review of primary and secondary packaging labels. Contact with national competent authorities and EMA.

Woerden, The Netherlands

Regulatory Affairs & Pharmacovigilance Animal Health

>Responsible for approx. 40 employees of which 4 PhD's, departmental and project budgets, investments, planning, and adherence to Environment, Healthy and Safety regulations and quality (GLP) requirements.>Responsible for timely assay development, assay validation and bioanalysis. Bioanalysis for small molecules, UPLC, TFC, LC-MS/MS and large molecules (Biotech), immunoassays, ELISA's, immunogenicity testing, neutralizing assays (cell culture) and characterization of antibodies (Octet, Biacore).>As from Feb 2008; Ad Interim position Section Head Chromatography in DBA-O department direct line responsibility for approximately 12 employees, including 1 PhD. Results; Appointed second Group leader. Renovated the GC-MS laboratory into a state-of-the-art LC-MS laboratory. Introduction of Symbiosis, TFC, and UPLC. >Stimulated development of technicians for sample preparation into fully trained LC-MS operators to obtain a more flexible and efficient organization.>Successfully passed regulatory compliance FDA inspection of a bioequivalence study. Prepared and led the FDA inspection, and follow up of 483 remarks.>Bioanalytical contribution to regulatory submission of European registration of Bridion, Elonva, Implanon and Nuvaring.>Test facility Manager GLP compliant facility; reduction of minor remarks from 6 to 4.

>Responsible for timely delivering of clinical supplies by coordinating all activities per project, such as planning, GMP manufactering, blistering/bottling, packaging, labeling, and release of Investigational Medicinal Product (IMP) for global clinical trials Phase I-III. Projects; Biotech (ELONVA) and small molecules (Arixtra, Idraparinux). >Introduced and chaired the Clinical Supplies kick-off meetings with members from CMC, Quality and regulatory departments.>Chaired international, multicultural, Clinical Drug Supply Teams.

Phd

PhD Thesis: Antibody mediated protection against Escheria coli infection in mice, at Medical Microbiology, Utrecht University.

Drs, Medical Biology