Trilogy holds regular Think Tanks for senior industry colleagues and thought leaders to gather and discuss key issues facing the industry. Each Think Tank begins with a presentation about current evolutions or constraints in a particular area of clinical development. This is followed by an open and lively discussion about what we, as a group, think the industry can be doing to take advantage of the evolutions or improve upon the constraints.
The goal is to share knowledge and experience, and together come up with ideas for how we can improve the many different processes involved in product life cycles. The Think Tank series covers a different topic each time. To minimise the effect on your working day, we run the Think Tanks as breakfast meetings (9:00-12:00). There is no cost to participate, all you need to do is bring your ideas and join in the discussion.
Past Think Tanks
December 15, 2020 | Virtual
Trilogy hosted its second virtual Think Tank on how to make the process of writing and coordinating a CTD submission dossier as efficient as possible and, ultimately, reduce the stress often associated with this activity.
The Think Tank was kicked off by presentations from Johan Telen (President at ImprovementatWork Inc.) and Douglas Fiebig (Senior Partner at Trilogy Writing & Consulting). The speakers shared their field-tested strategies, processes and tools for best practices in streamlining the CTD preparation process.
November 05, 2020 | Virtual
Trilogy hosted a discussion on writing Lay Summaries and their experience on how to overcome the unique challenges found when writing these types of documents.
- Louise Broge (Head of Medical Communication at LEO Pharma)
- Dr. Barry Drees (Senior Partner at Trilogy Writing & Consulting)
January 22, 2020 | London, UK
Trilogy hosted a discussion on writing Lay Summaries and their experience on how to overcome the unique challenges found when writing these types of documents.
- Louise Broge (Head of Medical Communication at LEO Pharma)
- Dr. Barry Drees (Senior Partner at Trilogy Writing & Consulting)
October 25, 2019 | Massachusetts, US
Trilogy hosted a discussion on how to make the process of writing and coordinating a CTD submission dossier as efficient as possible and, ultimately, reduce the stress often associated with this activity.
- Johan Telen (President at ImprovementatWork)
- Dr. Douglas Fiebig (Senior Partner at Trilogy Writing & Consulting)
April 26, 2019 | London, UK
Trilogy hosted a discussion on how to make the process of writing and coordinating a CTD submission dossier as efficient as possible and, ultimately, reduce the stress often associated with this activity.
- Johan Telen (President at ImprovementatWork)
- Dr. Douglas Fiebig (Senior Partner at Trilogy Writing & Consulting)
January 24, 2019 | North Carolina, US
Trilogy hosted a discussion on the implications that the disclosure and transparency regulations will have on producing clinical regulatory documentation and provided insight from an actual anonymization procedure, together with our speakers:
- Jo Anne-Marie Blyskal (Head of Global Regulatory Medical Writing and Data Disclosure, Teva)
- Dr. Julia Forjanic Klapproth (Senior Partner, President at Trilogy Writing & Consulting)
September 21, 2018 | London, UK
Trilogy hosted a discussion on the implications that the disclosure and transparency regulations will have on producing clinical regulatory documentation, together with our speakers:
- Robert Paarlberg (Principal at Paarlberg & Associates)
- Dr. Julia Forjanic Klapproth (Senior Partner, President at Trilogy Writing & Consulting)
March 15, 2018 | North Carolina, US
Trilogy hosted a discussion on how to make the process of writing and coordinating these responses as efficient as possible, together with our speakers:
- Dr. Art Gertel (President and Principal Consultant at MedSciCom)
- Dr. Julia Forjanic Klapproth (Senior Partner, President at Trilogy Writing & Consulting)
December 14, 2017 | Frankfurt, Germany
Trilogy hosted a discussion on the main advantages of the CDP, as well as the main challenges on writing this document and possible solutions, together with our speakers:
- Dr. Katrin Bernöster (Vice President Corp. Project & Portfolio Management at Biotest AG)
- Dr. Barry Drees (Senior Partner at Trilogy Writing & Consulting)
November 14, 2017 | London, UK
Trilogy hosted a discussion on the main challenges on PBRERs and RMPs and reviewer insights, together with our speakers:
- Dr. Stephanie Millican (Medicines and Healthcare products Regulatory Agency, MHRA)
- Dr. Lisa Chamberlain James (Senior Partner at Trilogy Writing & Consulting)
October 31, 2017 | North Carolina, US
Trilogy hosted a discussion on the challenge of measuring the service provided for medical writing – how do you define a good quality document and how do you measure the activities performed by medical writers, together with our speakers:
- Dr. Shari Bodnoff (Global Head of Operations, Regulatory Writing and Submissions at Novartis)
- Dr. Julia Forjanic Klapproth (Senior Partner, President at Trilogy Writing & Consulting)
November 29, 2016 | London, UK
Trilogy hosted a discussion on the challenge of measuring the service provided for medical writing – how do you define a good quality document and how do you measure the activities performed by medical writers, together with our speakers:
- Wayne Beazley (Director Medical Writing at Astellas Pharma)
- Dr. Julia Forjanic Klapproth (Senior Partner, President at Trilogy Writing & Consulting)
July 12, 2016 | Frankfurt, Germany
Trilogy hosted a discussion on every-day challenges involved in meeting the guideline on good pharmacovigilance practices (GVP), the challenge of writing and managing Risk Management Plans (RMPs), including the newly legislated Part VI.2 of the RMP (summary for the lay reader), and focused also on the potential changes and challenges posed by the updated guideline in consultation, together with our speakers:
- Sven Schirp (Head of Global Pharmacovigilance Writing at Boehringer Ingelheim)
- Dr. Lisa Chamberlain James (Senior Partner at Trilogy Writing & Consulting, UK)
December 15, 2015 | London, UK
Trilogy hosted a discussion on “Are we ready for the patient’s voice through social media in the benefit-risk assessment of drugs?” amongst a small group of peer experts and together with our speakers:
- Phil Tregunno (Signal Management and Quality Standards Unit Manager at MHRA)
- Sue Rees (EU QPPV, Executive Director at Amgen)
November 3, 2015 | Frankfurt, Germany
Trilogy hosted a discussion on the challenge of measuring the service provided for medical writing – how do you define a good quality document and how do you measure the activities performed by medical writers, together with our speakers:
- Chris Wichems (Director, Medical Writing and Disclosure, Clinical Research & Development at CSL Behring)
- Dr. Julia Forjanic Klapproth (Senior Partner, President at Trilogy Writing & Consulting)
June 18, 2015 | London, UK
Trilogy hosted a discussion on the challenges posed by the guideline on good pharmacovigilance practices (GVP) with a special focus on Risk Management Plans (RMPs), together with our speakers:
- John Solomon (Head of Pharmacovigilance at Sanofi)
- Dr. Lisa Chamberlain James (Senior Partner at Trilogy Writing & Consulting)
April 23, 2015 | Frankfurt, Germany
Trilogy hosted a discussion during which we explored strategies for how to make sure that your Clinical Development Programme meets not only the needs for regulatory approval, but also the needs for market access and reimbursement, together with our speakers:
- Dr. Boris Pfeiffer (Director Global Evidence & Value Development, Merck, and representative in the IMI GetReal project)
- Dr. Thomas Wagner (Medical Writing Manager at Trilogy Writing & Consulting)