This webcast is for all those who want to reach their success targets easily by avoiding torpedoing pitfalls with the knowledge from a quick and comprehensive onboarding about the complexity of the pharma-world. You will get a quick and profound ride through the current health regulations with an overview on Pharmacy Legislations, Regulations and Standards as well as on different roles and responsibilities. This online course is designed to raise awareness of common pitfalls in pharma/healthcare projects and to enable a well-considered project planning and more efficient collaborations, timewise and budget wise.

This course is especially tailored to questions and needs of people new in the healthcare environment:

• Agency employee (e.g. account, creative, copy, art) with healthcare clients
• Pharma/Healthcare managers (e.g. marketing, regulatory, medical affairs, pharmacovigilance, R&D) new in business and/ or interest about the bigger picture
• Clinical Research Associates and other employees of CRO

Participants will gain insights to:

• Complexity of pharma/healthcare environment: different players, roles and responsibilities
• Overview legal and company internal frameworks
• Awareness about common pitfalls in projects

In this 45 minutes webcast, Dr. Ursula Köhler is going to speak about:

• Business complexity: Healthcare environment, Player Complexity, Company structures
• Legal framework: Regulatory status (Rx, OTC, Biopharmaceuticals, Generics, Food, Cosmetics, Medical Device) und implications, German Regulations: AMG, HWG and more, Health Claims Regulation, Differences by target group (patients vs. HCPs)
• Companies internal framework (SOP, LMR, e.g.)
• Project pitfalls (external collaborations, content challenges, expectation management)

The fee for this webcast is 39,- EURO (plus GERMAN VAT)



Dr. Ursula Köhler, HealthCare & Business Consultant
As a registered Pharmacist (PhD), Ursula was able to gain more than 15 years’ industry experience in global and local Medical Affairs (Germany, Global) in top 10 pharma companies. In her role as a medical director in international medical communications & health focused advertising agency she completed the picture for efficient collaboration between different player. Her broad operative and strategic view on current healthcare challenges (Rx, Generics, OTC; food supplement) enabled her to be a well-recognized partner for clients as the owner of HealthCare & Business Consultancy. Beside the basic essentials, Ursula focuses her knowledge and insights on new approaches in collaboration, personality development, new work, digital in scientific affairs, purpose in medical communications, values and cultur.