Aleksandra Bieniek
Attorney-at-law
Aleksandra has started her career in a boutique law office specialising in Life Sciences, Intellectual Property Law and personal data protection. Then, she joined one of the biggest Polish law offices where she provided legal advice to a pharmaceutical sector.
She has gained experience in inspection-related issues. She supported manufacturers, wholesale outlet owners and intermediaries in the trade of medicinal products at every stage of proceedings. She is also well familiar with the topics concerning medications authenticity.
In contacts with Clients she takes care of clear communication. She seeks tailor made solutions, not losing sight, simultaneously, of the market specifics and the attitude of supervision authorities.
Aleksandra is passionate about Italy, books on alpinism and Polish female painters. She spends her leisure time actively, cycling in the woods and, recently, also on the tennis court.
Experience
Selected projects:
- Devising strategy before inspection at medical products trade intermediary, as well as providing support during and after the inspection,
- Obtaining authorisations to run a pharmaceutical wholesale outlet of human and animal medications,
- Providing support to a manufacturer in the proceeding succeeding in convincing Chief Pharmaceutical Inspectorate (GIF) to change disadvantageous interpretation of the provisions,
- Devising a strategy of cooperation between one of the leading pharmacy chains and wholesale outlets suppliers,
- Conducting documentation audit of medicinal products manufacturer from a regulatory perspective,
- Managing contract division in one of the leading pharmaceutical companies (big pharma),
- Convincing to attitude change concerning verification of medicinal products authenticity (‘serialisation’) on the regional level and coordination of concluding designation agreements,
- Support for the automation of a pharmaceutical wholesale outlet.
My specializations