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.
JANA BRAJDIH ČENDAK
Jana is a Medical Doctor and joined Billev Pharma East in 2018 as a Medical Advisor. She started her career as a practicing physician, specialising in Emergency Medicine. She worked in the Public Health sector as well as in her private practice. Later on, she worked as a Medical Advisor and Head of the Medical Department in Sanofi and Novo Nordisk.
In her current position Jana is responsible for the preparation and review of clinical, non-clinical and pharmacovigilance documents, as well as for other activities related to the preparation of marketing authorisation applications. She also performs consultancy tasks for clinical trials and supports other regulatory and reimbursement activities, as well as medical consultancy for strategic operations and planning.
In her free time she particularly enjoys diving and spearfishing, she is also a keen sailor.
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.
During her business career as a master of pharmacy, Barbara has already worked in various fields of pharmacy.
She started her business career as a sales representative at Simpss, later worked in a pharmacy as a pharmacist and as a Head of pharmacy. Ten years ago she joined Sandoz as a regulatory affairs manager where she handled life cycle of the registration documentation of medicines for Slovenia. Then she moved to the quality department to gain additional knowledge on quality of medicinal products. She was responsible for the compliance of documentation and procedures in the Analytical Science and Technology Group (AS & T). She also gained knowledge from quality control in the analytical field. She participated in the group for the process of change control of DMF and CEP for ingredients and was also checking the compliance of ingredients for production. After gaining sufficient experience, she was appointed as the qualified person for batch release of medicines, including clinical trial batches, forall countries of this planet. As a qualified person for batch release, she was also entered into JAZMP register in the name of the company.
In Billev Pharma East she also covers the field of quality, good manufacturing practices and good distribution practices and acts as contract qualified person for batch release of medicines for other companies.
Her free time is dedicated to activities that include a healthy lifestyle. She also enjoys artistic creation where she finds inspiration and relaxation.
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.