Pharmaceuticals Law

 

This is a fast growing sector and is simultaneously subject to dynamic structural transformation.
It is one of the most densely regulated markets. Enterprises operat-ing in this environment face manifold challenges.

For many years we have been advising leading international pharmaceuticals manufacturers, medical devices manufacturers, biotech enterprises, hospitals, care homes, health insurance companies and service providers in the health sector. Our experts counsel our clients on their day-to-day business, on regulatory issues, tax structures, compliance questions, product liability cases, other disputes and during larger projects.

We also assist our clients during corporate acquisitions or sales, joint ventures and other transactions. Our M&A lawyers know how drug manufacturers secure and defend their market shares, how the establishment and operation of hospitals are financed, how medical device manufacturers develop or purchase innovative prod-ucts. Without this specific know-how, the due diligence examination in transactions is at best inefficient, and without this know-how the contract does not secure the value of the transaction.

 

Current topics of pharmaceuticals law

Lecture content

This lecture covers the current topics of pharmaceutical law jurisprudence and leg-islation at any time.

Target group

Specialists, legal practitioners in general, managing directors

Duration

45 - 60 minutes

Distinction between drugs, medical devices & Co.

Lecture content

This lecture explains the criteria for the regulatory classification of a product and the consequences.

Target group

Legal practitioners and people without legal expertise working in the healthcare sector

Duration

Flexible, minimum 60 minutes

Current topic: the new European Medical Device Regulation (MDR)

Lecture content

This lecture provides an overview of the amendments in medical devices law. The treatment of special topics such as transition periods, for example, is possible.

Target group

Legal practitioners and people without legal expertise working in the healthcare sector

Duration

Flexible, minimum 30 minutes

Drugs, medical devices and Co. – What can and can’t you say in an advert?

Lecture content

This lecture offers a general overview. The treatment of special topics such as ad-vertising with the results of studies, for example, and the revisions pursuant to the Amendment of the German Act on Advertising in the Healthcare Sector (HWG-Novelle) are possible.

Target group

Legal practitioners and people without legal expertise working in the healthcare sector

Duration

Flexible, minimum 30 minutes

The competitive process in the healthcare sector

Lecture content

This lecture provides a general overview and explains strategies for the competi-tive process in the healthcare sector.

Target group

Legal practitioners and people without legal expertise working in the healthcare sector

Duration

Flexible, minimum 60 minutes

Development and distribution of wearables and apps in the healthcare sector – allocation of legal responsibilities

Lecture content

This lecture provides an overview of the provisions to be observed by the various actors in connection with health apps pursuant to data protection provisions, crimi-nal law as well as the laws regulating medical devices and advertising in the healthcare sector.

Target group

Legal practitioners and people without legal expertise working in the healthcare and IT sectors

Duration

Flexible, minimum 30 minutes

Granting benefits to service providers

Lecture content

This is a lecture presenting the provisions to be observed when granting benefits.

Target group

Legal practitioners and people without legal expertise working in the healthcare sector

Duration

Flexible, minimum 30 minutes