CHRISTINE VAN HOOF

Project Lead in GSK Global Regulatory Affairs (GRA) vaccine development portfolio

• Developing regulatory strategy pathways for new vaccine assets
• Preparing and attending meetings with internal Governance Boards
• Preparing, actively contributing and attending meetings with major Regulatory Authorities:

● EMA and national Scientific Advices for GSK’s new vaccine

assets

● Several consultations with FDA for GSK’s new vaccine

assets: Type C meetings, pre-IND meetings, End of Phase 2

meetings

• GRA representative in new vaccine assets project matrix teams, interacting and building relationships with several stakeholders from different functions to integrate the regulatory strategy throughout the different phases of the Clinical Development Plan
• Leading major regulatory submissions from regulatory strategy building to submission at the study level (e.g., Clinical Trial Applications including EU CTR experience, IND amendments) and at the project level (e.g. new IND applications, consultations with Regulatory Authorities, paediatric study plans)

● Developing internal strategic regulatory documents to
define the regulatory submission strategy of different major
submission dossiers
● Guiding and reviewing of complex regulatory documents for

various applications for multiple Regulatory Agencies

• Mentoring and coaching GRA team members to support the regulatory submissions for new vaccine assets

Preceeding regulatory activities as Project Lead in GSK GRA vaccine development portfolio as described above with the following major achievements:

• Developing the Global Regulatory Plan for new vaccine assets, including endorsement by internal Governance Boards
• Successful outcome of FDA consultations setting the regulatory strategy for the clinical development of new vaccine assets (pre-IND meetings, Type C meetings)
• Successful submission and approval of Priorix BLA

Preceeding regulatory activities as Project Lead in GSK GRA vaccine development portfolio as described above with the following major achievements:

• Successful outcome of FDA consultations setting the regulatory strategy for the Priorix BLA submission (Type C meeting, pre-BLA meeting)
• Successful submission and approval of Priorix BLA

Clinical Regulatory Affairs Lead in MMR/V vaccine life cycle management (2016-2019):

• Developing, writing and reviewing of regulatory documents for various applications for multiple Regulatory Agencies according to high quality standards (e.g. major labelling variations, Article 30 referral procedure, …)
• Clinical RA key stakeholder in different labelling activities
• Representing MMR/V GRA and actively contributing in meetings with different stakeholders within GSK

Experience in registration management in GRA MMR/V life cycle management portfolio (2016-2019):

• Thorough knowledge of submission routes and regulation in EU for products authorised by central, mutual recognised and national procedures
• Highly experienced in completion of regulatory dossiers for clinical and technical variations, including experience in Module 1 preparation for eCTD submission
• Daily contact with GSK LOCs and Hubs to optimise the regulatory submission strategy, to support approval and to ensure timely supply in specific countries and regions
• Close collaboration with different stakeholders within GSK to ensure regulatory activities are matching supply demand, especially in key markets
• Thorough knowledge of EU, US and international regulations on submission procedures

RA representative in Clinical Regulatory Excellence Team supporting submissions for different projects:

• Writing of regulatory documents (e.g. clinical summaries, clinical overview, briefing documents, ....) for various applications for multiple Regulatory Agencies according to high quality standards
• Support preparation of CDE Panel meeting for registration of GSK’s HPV vaccine in China (2012)
• Subject Matter Expert within GRA Department for transversal initiatives to improve and standardise internal processes to increase compliance to Regulatory Legislations (e.g. Expert on Article 46 of the Paediatric legislation)

Scientific Writer for GSK in HPV vaccine clinical team:

• Developing, writing and reviewing of a variety of clinical study documents (protocols, reports, investigator brochures, general investigational plans) for vaccine efficacy trials and other vaccine-related studies
• Active participation in the preparation of presentation material for the Advisory Committee (VRBPAC) to achieve approval of GSK’s HPV vaccine by the FDA.
• Writing of scientific documents for exploratory and assay validation studies and participating in scientific discussions with the Clinical Laboratory Department of GSK and their international collaborators.

• Writing a variety of clinical study documents (protocols, reports, investigator brochures, safety narratives, Safety/Efficacy section of Investigational Medicinal Product Dossiers) for a wide range of drug indications (e.g. HIV) at different clinical development stages for different pharmaceutical sponsors.

• Executing research in the field of molecular cell biology and signal transduction pathways, writing of scientific publications for peer reviewed journals, writing of research project applications for financial grants, supervision of research projects of master and PhD students, participation in symposia and congresses within the research field and presentation of research results by posters or lectures.
• Teaching at the Faculty of Medicine. I composed and wrote a syllabus for the course "Cell cycle-apoptosis-oncogenes-tumour suppressors".
• During this period, I worked for 2 years at the laboratory of Molecular Cell Biology, Faculty of Sciences, K.U.Leuven, and I did several international study journeys.

During this period, I successfully prepared and acquired my PhD and educated practica to university students at the Faculty of medicine