Pekka Lukkari is a Global Regulatory Affairs professional with 30 years experience gained working in Finland, Germany and Switzerland. Pekka has demonstrated success working with different companies in supporting regulatory applications e.g. Clinical Trial Applications, Marketing Authorization Applications, Scientific Advice, Orphan Designation Applications and Paediatric Investigational Plans and leading teams in developing regulatory strategies that are appropriate and take advantage of global regulatory systems and processes, in particular the application of innovative regulatory pathways, to expedite development and license approvals. 

Pekka Lukkari has successfully lead and managed the therapeutic area teams of addiction, anaesthesia, endocrinology, fertility, inflammation & immunology, oncology, ophthalmology and osteoporosis i.e. being responsible for all regulatory aspects related to development projects and product registrations.

He has registered (been part of the team / team leader) 13 new Rx products (both biotech and chemicals among which there have been several orphan medicinal products), 28 new strengths / indications and 11 medical devices in all ICH countries (EMA, FDA and MHW) as well as in Australia, Canada and Switzerland according to self developed and approved global regulatory strategies.

Managed successfully with increasing responsibilities regulatory personnel since 2002 in Serono / Merck Serono and in several other companies (as consultant).  The largest team (varied with the time depending on the organisation of regulatory function) was 27 regulatory administrators and professionals.  The expertees covered were above mentioned therapeutic areas and regulatory operations (+20 years).

Pekka Lukkari is a regulatory expert focusing on CMC / quality aspects of regulatory requirements and documents i.e. writing, review, assessment and approval of documents for clinical trials and licence applications.

He has practical experience in designing and setting-up RA organisations and implementing new RA organisational structures. Pekka Lukkari is also Swissmedic approved responsible person (QP).