Tiziana von Bruchhausen

Tiziana specialises in pharmacovigilance writing and has gained over 10 years’ experience while working in various roles for mid-sized and large pharmaceutical companies. She is currently employed as a principal pharmacovigilance writer at Boehringer Ingelheim. Her tasks and responsibilities cover pre- and post-submission activities related to the global strategic planning and the preparation of pharmacovigilance documents with a focus on DSURs, RMPs, PSURs, and health authorities’ assessment reports. Tiziana actively promotes the professional role of medical writers in pharmacovigilance through workshops and lectures Europe-wide and has served as a session chair at international conferences. She is an active volunteer at the European Medical Writers Association (EMWA), where she has been chairing since 2017 the Pharmacovigilance Special Interest Group Committee. She was Vice President of EMWA in 2017-2018 and President in 2018-2019.

Contributions

Pharmacovigilance - Volume 31, Issue 2

The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…

Pharmacovigilance - Volume 31, Issue 1

The Pharmacovigilance section of this issue is related to the first Meet & Share online event held in December 2021 by the EMWA Pharma - covigilance Special Interest Group (PV SIG) – with more than 70 attendees! Tiziana von Bruchhausen (editor)

Pharmacovigilance - Volume 30, Issue 4

Dear members, I am delighted to launch the Pharmacovigilance (PV) section in this journal issue! Those of you who have been around for a while may know that, in the past, PV-related articles were published either as feature articles or as guest…

Regulatory Matters - Volume 30, Issue 4

One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…

Risk management plans in the EU: Managing safety concerns - Volume 29, Issue 3

The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…

Same but different: Basic tools for biosimilar and generic pharmacovigilance writing - Volume 28, Issue 2

Biosimilars are medicinal products, which are highly similar to an already authorised biological product; generics are identical copies of an already authorised chemical entity. As for any other medicinal product,biosimilars and generics require the…

President’s Message - Volume 28, Issue 2

President’s Message - Volume 28, Issue 1

EMWA’s spring conference will offer, once again,an impressive variety of workshops, expertseminar series (ESS), lectures, networkingmeetings, and a symposium on the importanttopic of the real-world evidence. Our members,whatever their degree of…

President's Message - Volume 27, Issue 4

Dear EMWA Members, Exciting news from our conference in Warsaw! Besides the excellent conference programme, there were a few updates and initiatives going on “behind the curtains”. First of all, I would like to thank our workshop leaders, members of…

President’s Message - Volume 27, Issue 3

In the apparently quiet time after the spring conference in Barcelona, much has been going on in the background of the association’s life. Before moving to the details of our activities, I would like to mention that two veteran members of the Head…

President’s Message - Volume 27, Issue 2

Dear EMWA Members,In my first President’s message I would like to say how honoured I am to represent EMWA and how excited I feel about the tasks of my new role. I would like to thank Abe Shevack and the other Executive Committee members for their…

EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans - Volume 26, Issue 3

Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated…

Medical Communications - Volume 25, Issue 3

Anyone working in pharmacovigilance (PV) will already have spent many months working their way through the ever changing updates and reforms to the Risk Management Plan (RMP), and the newly legislated RMP summary. Those not working in PV will…

Pharmacovigilance medical writing: An evolving profession - Volume 24, Issue 2

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…