PETER DE MAYO BILLEV
Peter is first and foremost an international pharmacist, qualified in Copenhagen, Denmark 1962.
Since 1963 he has worked in Regulatory Affairs and Marketing in the international pharmaceutical industry.
Peter founded Billev Pharma ApS in 1978 and also founded Billev Pharma East in 2007.
Over more than 40 years, Billev Pharma and Billev Pharma East grew to become central partners in the Regulatory Affairs environment.
All these years it was important for Peter that the company was ahead of other companies in the field, regarding all regulatory and later also pharmacovigilance developments, rules and regulations. To be first with e-CTD, first with Article 57 solutions, first with PSMF.
During the last 20 years Peter has been actively involved in the Medicines For Europe Association (former EGA). This has been vital in order to be able to meet all new challenges, with updated knowledge, even before they surfaced.
Katja has a Master in Pharmacy and has been with Billev Pharma East since September 2008, responsible for business development, regulatory affairs and pharmacovigilance, positioned as Director of Regulatory Affairs and EU-QPPV. She started her career in VetConsult Pharma working in various areas with veterinary medicines and afterwards joined Sandoz as Regulatory affairs manager and later as a Head of the regulatory affairs department. Over the years she gained many experiences in regulatory affairs of human and veterinary medicinal products and medical devices. She is involved in regulatory strategies, electronic submissions, pharmacovigilance, project management, launch management, leadership and is working with all European Competent Authorities to obtain and maintain the life cycle of the products. She is a member of different Medicines For Europe working groups and was also a Member of the EMA eSubmission Change Control Board from initial set up until the implementation of the new EU telematics governance structure.
Katja is spending her free time with her family, practicing yoga, tai chi and enjoying nature. She also likes cooking and spending time with her friends.
ANA KRAIGHER TKAVC
Ana has been working as regulatory affairs manager for many years, started at Sandoz in 2005, and since 2015 at Billev Pharma East. She is Doctor of Veterinary Medicine. She started her career at Bayer Pharma as medical representative and afterwards she joined Lek Animal Health as researcher in Research and Development Department, where she was responsible for safety and efficacy part and for development of veterinary medicines. Later she joined regulatory affairs team in Development Center in Sandoz where she worked as regulatory affairs manager for human medicines and was awarded for her work also within development teams. She was also responsible regulatory manager for respiratory products, regional manager and RA/QA coordinator. Over the years she gained many experiences in regulatory affairs of human and veterinary medicinal products, regulatory strategies, project and launch management, planning and preparation of regulatory dossiers with Quality overall summaries for new applications and for variations for EU, US, CA, AU and rest of the world to obtain and maintain the life cycle of the products.
In her spare time Ana likes to be with her family, especially being active in nature, running, mountain biking, windsurfing and back-country skiing.
VISHAL MANJIBHAI GHORI
Vishal works as medical advisor and his day-to-day work involves medical writing of clinical, non-clinical and pharmacovigilance documents and reviewing them for marketing authorisation application dossiers. His daily work also includes all other pharmacovigilance activities necessary for MAH compliance. He is involved in consulting on clinical trials and he also works across the planning process, supporting the senior consultants in various regulatory and reimbursement applications.
He is a medical doctor. After graduating from medical school, his interest in clinical and basic research led him to pursue MD in pharmacology and MRes (master of research) in biomedical sciences. Along with his medical background, Vishal brings expertise in clinical and pre-clinical pharmacology to Billev Pharma East to meet our client’s needs in these areas.
When he’s not in office, Vishal spends his spare time reading, cooking and watching documentaries. Equally active, he enjoys running and hiking whenever he finds the time.
Klemen is Regulatory Affairs Manager and Medical Support Manager. His office responsibilities include clinical and preclinical work, pharmacovigilance activities, statistical analysis and pharmacoeconomic support at reimbursement applications. His work supports various medical projects and activities relating to clinical and bioequivalence studies. He also helps at various regulatory affairs activities.
He holds PhD in pharmaceutical sciences and his thesis was in the field of pharmacoeconomics. His work experience so far has been particularly in the field of clinical research design and monitoring. Along with his statistical background he has sufficient knowledge in analysing various clinical studies. He also offered expert support in various medical projects and was in charge for cost-effectiveness sections of reimbursement dossiers.
In his spare time, Klemen spends as much time as possible in various sport activities, with running being his primary passion. His main area of interest and free-time research are nutrition and physical activity and their relevance to healthy lifestyle.
NINA EVELINA KERŠMANC
Nina has a Master in Pharmacy and she started her work at Billev Pharma East as an apprentice, passionate to get to know the field of regulatory affairs. She is now employed as a regulatory affairs officer and she is supporting the team at daily activities.
Her work includes preparation and maintenance of registration documentation for different regulatory applications, building eCTD and NeeS sequences and translation of product information. She also participates in certain pharmacovigilance activities. Since she helps with various regulatory activities, she works closely with all other experts of our company.
In her free time Nina spends as much time as possible with her loved ones and most enjoys doing long walks in nature. She also likes singing and has a passion for cooking and baking.