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BMI SYSTEM was proud Platinum sponsor, exhibitor and moderator of the 3rd annual Pharma LawConvention event in Bucharest, Romania, on the 2nd and 3rd of April.

The event provided a unique platform designed to assist legal counsels, compliance and regulatory officers in understanding of the current and forthcoming challenges in transparency, competition, clinical trials, or in the very debatable area of parallel trade.

 

Major highlights:

1. An excellent interactive workshop led by Laurent Clerc, Regulatory Affairs Expert at BMI SYSTEM, entitled “How to implement transparency procedures and disclosure specifications”. Laurent has also discussed other topics, including “What is transparency of HCP payment?” or “How to manage European and local rules of disclosure in the same process?” and has provided a full overview of end-to-end disclosure processes for transfers of value.

As Laurent states, “We decided to change the format of our workshop. Instead of simply presenting the various subjects, we’ve included the audience within a typical transparency / regulatory process and interacted with people to explain their own company’s processes on the white boards.

2. BMI SYSTEM had the privilege to meet Richard Bergström, EFPIA director, who expressed his interest in discussing further our strategy and futures perspectives.

3. Many discussions with participating customers (see below for a full list).

4. We will be planning a local event on May 29th in Bucharest in association with the ARPIM (Romanian Association of International Medicine Manufacturers) and DLA Piper (a global law firm with 4,200 lawyers located in more than 30 countries).

 

Various subjects discussed during this event:

COMPLIANCE/TRANSPARENCY

• Transparency, aggregation and IT systems
• Local vs. global regulation
• Transparency rules by EFPIA & its understanding by EU representatives
• Cross-Border HCP Engagement

COMPETITION

• Project “European Stakeholder Model (ESM)” to fight against counterfeit medicines
• Pay for delay
• Deregistration/dealings with regulatory authorities
• Patent settlement

PARALLEL TRADE

• Re-Export, Good Distribution Practice (GDP)
• Medicine shortages
• New rules on importing active pharmaceutical ingredients into the EU

CLINICAL TRIALS

• Impact of regulations and polices
• Regional overview – Case study
• Right of access vs. Commercially confidential information

 

Companies which have participated : ABBOTT Laboratories Georgia, Abbvie, Actavis, Alpen Pharma Group, Amgen, Arpim, Astellas, AstraZeneca, Baxter, Bayer, Bayer – Romania/Bulgaria, BBraun Medical, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, EFPIA, Eli Lilly Company, Fresenius Kabi, GSK, IPSEN, Ivermedi, Janssen Romania, JGL, Merck, Novo Nordisk, Omega Pharma, Pfizer, Roche, Sandoz, Sanofi, Sanofi Aventis Georgia, Servier Pharma, Sono-Pharma, TEVA.

 

Edit 07/05/2014: to download the presentations given on the day, please send your name and email adress at n.danicourt@bmi-system.com. We will be pleased to send it to you. Thank you

 

Photos of the event

Pharma LawConvention photos

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