EU Pharmaceutical Law Forum

Date: 16 May 2017

Time: 08:00

Duration: 3 days

Location: The Hotel Brussels, Brussels

Cost: From £1199

Organiser: KNect365 Life Sciences

Web Link: https://lifesciences.knect365.com/pharmalaw/

Description:

EUROPE'S LEADING PHARMACEUTICAL LAW CONFERENCE

Competition Law & Patent Litigation

EU Commission keynote: feedback on competition law;
Lundbeck case: lessons learnt on reverse payment pattern settlements and implications for industry;
Dominance through excessive pricing: current status and new case law;
SPCs: analysis and current shortcomings of the regulation.

Regulatory Frameworks

EMA and European Commission keynotes on the regulatory landscape;
An update on regulatory IP rights: Orphan drug and paediatric exclusivity and RDP;
EU Clinical Trials Regulation: examine implementation requirements and assess the impact of Brexit;
Pharmaceutical marketing: Promotions, advertising and digital media - what are the legal challenges?

Compliance: Data Privacy & Anti-Bribery

EU General Data Protection Regulation: obligations and sanctions for non-compliance;
Exploring current privacy policies to ensure alignment with new requirements including mobile apps and e-health;
Clarity on transparency: what is the status and where will it be in the future?
Anti-bribery: conducting an internal investigation and examining the legal challenges.

Licensing & Collaboration Agreements

Deal structuring: examine the increasingly innovative nature and associated challenges;
Antitrust implications of licensing and collaboration: in-house and private practice feedback;
Early stage clinical licensing deals: potential pitfalls and how to avoid them;
Due diligence: Licensing options and IP considerations.

Brexit and the Impact on the Industry

The UK's exit from the EU will have a significant impact on pharmaceutical law. Hear Europe's leading experts debate and discuss Brexit's impact on key areas including:

SPC regulations;
Regulatory IP rights;
Unified Patent Court;
Regulatory Frameworks.

Implementing the European Medical Device Regulations

Join your peers at our evening seminar and dinner as our expert speakers examine the new European Medical Device Regulations and the impact on industry

Assess the transitional provisions for implementing the Regulations: implementing the delegated acts;
Understand the increased obligations on economic operators;
Examine the rules on liability and transparency;
Classification of products: what is the current state of play?