Akiko Hihara
Managing Editor
Asia
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Akiko Hihara is Managing Editor, responsible for the regulatory intelligence of the Asian countries. She joined Thomson Reuters in 2001 and has actively contributed to the creation and enhancements of regulatory content pertaining to drugs, biologics and medical devices for Japan, China, Taiwan, South Korea Country modules.
After graduated with Bachelor of Arts with English literature in Japan, she held a number of editorial and publishing roles within the publishing companies in Tokyo and London. She has also spent 2 years working on strategy projects for healthcare and pharmaceuticals with management consulting firm in London.
- 13th DIA Japan Annual Meeting (13-15 November 2016, Tokyo, Japan), Conference report available in CCI
- 12th DIA Japan Annual Meeting (15-17 November 2015, Tokyo, Japan), Conference report available in CCI
- Article: Expectation and Challenge for New Regulatory Framework of Regenerative Medicines (8 December, 2014)
- 11th DIA Japan Annual Meeting (16-18 November 2014, Tokyo, Japan), Conference report available in CCI
- Article (co-production): Japan and China: Challenging Strategies in the Global Device Market (23 October, 2014)
- 10th DIA Japan Annual Meeting (6-8 November 2013, Tokyo, Japan), Conference report available in CCI
She has made several interventions at international conferences and contributed to the following thought leadership activities:
- 11th DIA New Drug Conference, Tokyo, Japan (17-18 April 2017) l Conference report available in CCI
Anne Lecocq
Senior Manager
Europe
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Anne Lecocq is a Senior Manager of Regulatory Intelligence and is responsible for managing the Cortellis Regulatory Intelligence EU and US regulatory teams. She has 13 years of experience in Regulatory Affairs and Regulatory Intelligence. Anne is responsible for CRI EU&US content and defines the general research and development strategy for European and North American content. She joined the editorial team in 2008 and has actively contributed to the creation of new content and enhancements for drug and device information. Anne is a chemist with a master's degree in Regulatory Affairs. She has worked for the pharmaceutical industry in Regulatory Affairs and has experience in the CMC field. Anne is involved in regulatory associations and regularly participates in regulatory networking events.
Joaquín Fernández
Managing Editor
Europe
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Joaquin Fernández is Managing Editor, responsible for the regulatory intelligence of 19 countries (including Germany, Turkey, Spain and Russia). He joined Clarivate Analytics in 2015.
Joaquin is chemist and studied in the University of Barcelona. He has more than 15 years of experience in the industry, including quality analysis and laboratory management.
During the last 6 years, before joining the company, he worked as Regulatory Affairs Manager in a consultancy company, providing full regulatory support (new registration, MA maintenance, submission, strategy, etc) to international pharmaceutical companies, particularly for medicinal products but also for medical devices, mainly for the Spanish and Portuguese markets.
Monia Tumminello
Managing Editor
Regulatory Intelligence
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Monia Tumminello is Managing Editor, responsible for the regulatory intelligence of several countries in Europe. Since she joined in the company actively participates in the development of the regulatory content, to provide comprehensive views on regulatory topics arising within Europe. Monia is a graduated pharmacist from the University of Pavia (Italy) and holds a Master Degree in Regulatory Affairs from the University of Barcelona (Spain). Before joining Clarivate Analytics, she worked as a Regulatory Affairs Specialist in several Pharmaceutical Companies where she was in charge of post-marketing authorization activities, such as variations, renewals and advertising in the EU as well as registration of a new medicinal product. Monia has 5 years of experience in Regulatory Affairs.
She has made several interventions at international conferences and contributed to the following thought leadership activities:
- Annual DIA EuroMeeting, Glasgow, UK (March 2017) | Conference report available in CCI
- Annual TOPRA Symposium, Amsterdam, Netherlands (September 2016) | Conference report available in CCI
Marta Guinart
Managing Editor
Regulatory Intelligence
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Marta Guinart is Managing Editor, responsible for Regulatory Intelligence of several countries in Europe. Since she joined the company she actively participates in the development of the regulatory content, to provide comprehensive views on regulatory topics arising within Europe. Marta is pharmacist by the University of Barcelona. She also holds a Master Degree in Regulatory Affairs and on Monitoring of Clinical Trials by the University of Barcelona. Before joining Clarivate Analytics, Marta worked as Regulatory Affairs Specialist in several Pharmaceutical Companies where she was in charge of both Medicinal Products and Medical Devices in European and International Markets. Marta has 7 years of experience in Regulatory Affairs.
Samirah Hamaui Cuardrado
Managing Editor
Regulatory Intelligence
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Samirah Hamaui is Managing Editor, responsible for the regulatory intelligence of Israel, Jordan, Kenya, Nigeria and South Africa. She joined Thomson Reuters in 2016.
Samirah is Pharmacist from the University of Miguel Hernández (Spain) and holds a master degree in the Scientific Departments of the Pharmaceutical Industry from the University of Barcelona.
Before joining Thomson Reuters, she began her regulatory career working at Amgen S.A. and later at Almirall S.A. (Spain), working in new registration products and roll-out of marketed products in Middle East and African countries.
Rosanna Melchior
Senior Project Manager
Canada, Asia Pacific and Middle East & Africa
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Rosanna Melchior leads the Rest of the World (ROW) team responsible for the regulatory intelligence in Canada, the Asia Pacific, Middle East Africa and Latin America regions. She is also responsible for Cortellis Global Regulatory Comparison. Rosanna is a registered Pharmacist from the University of Padua (Italy) holding a Master Degree in Regulatory Affairs from Paris XI University (France). She began her regulatory affairs career at Pfizer UK and later moved to Aventis in France, prior to joining Thomson Reuters in 2002. She is an active contributor of thought leadership activities, having published regulatory articles and made several interventions at international conferences and at associations’ events.
- 8th China DIA Annual Meeting (15-18 May 2016, Beijing, China), Conference report available in CCI
- 4th DIA African Regulatory Conference (27-28 April 2015, Dakar, Senegal), Conference report available in CCI
- Article: Carving the Path to Regulatory Harmonization in Africa, Life Sciences Connect Blog, May 2015
- DIA Webinar ‘Certificates of Pharmaceutical Products for Regulatory Submissions’, invited speaker, May 23, 2013
- DIA Asia Regulatory Conference (28-30 January 2013, Singapore), Conference report available in CCI
- 48th Annual DIA Meeting (24-28 June 2012, Philadelphia, PA), poster presenter ‘Implementation status of CTD, eCTD and paper-free applications: a global overview.’
- 47th Annual DIA Meeting (19-23 June 2011, Chicago, IL) speaker on ‘How Transparent are Regulatory Agencies with regard to Review Timelines? A Global Review.’
- Article: A Time for Compassion. What Canada, the EU, and United States are doing to update their compassionate use regulations, Applied Clinical Trials Magazine, September 1, 2007
- 13th Applied Clinical Trials Meeting (October 2006, Amsterdam, Netherlands), keynote speaker on ‘The emergence of Compassionate Use’
- Article: E-Train to Retain, Pharmaceutical Executive Europe, November 1, 2006
- 18th DIA EuroMeeting (March 2006, Paris, France), speaker on ‘Compassionate Use Programmes in North America, Australia and Europe: Overview of Authorities and Sponsor’s Roles and Responsibilities’
https://fr.linkedin.com/in/rosanna-melchior-20a8551b
Zeineb Merimi
Managing Editor
Middle East & Africa, Australia and Israel
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Zeineb Merimi is Managing Editor, responsible for the regulatory intelligence of the Middle East & North Africa (MENA) in addition to Australia and New Zealand. She joined Thomson Reuters in 2009 and since then she brought her regulatory expertise and language skills in the development of the MENA Country modules: Saudi Arabia, GCC, United Arab Emirates (2010), Egypt (2011), Lebanon (2012) and Tunisia (2012).
Zeineb is a graduated pharmacist from the University of Monastir (Tunisia) and holds a master degree in Regulatory Affairs from Paris XI University (France).
Before joining Thomson Reuters, Zeineb worked within pharmaceutical companies and contributed to different projects, such as the transfer of drugs manufacturing in Tunisia and the registration and regulatory follow up of products with local structures (affiliates or agents) in Middle East and North Africa countries.
- 11th Middle East Regulatory Conference (MERC), (17-18 November 2015, Riyadh, Saudi Arabia), Conference report available in CCI
- Article: “Harmonization…but also Innovation” Life Science Connect Blog, December 2015
Marie Domitille Petit
Regulatory expert
Europe
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Marie Domitille Petit leads a team managing regulatory information for Cortellis, providing regulatory intelligence content for Cortellis Regulatory Intelligence in the EU regulatory environment. Since joining in 2009 she has actively contributed to the development of new regulatory content in Cortellis, providing comprehensive views on hot regulatory topics surrounding medicinal products and medical devices arising within the European Union.
Marie Domitille gained thorough knowledge from previously working in different countries, at the European Medicines Agency as well as within an industrial setting. She is a registered PharmD from the University of Angers (France) and holds a Masters Degree in Regulatory Affairs from Paris-XI University (France).
She has made several interventions at international conferences and contributed to the following thought leadership activities:
- Annual DIA EuroMeeting, Glasgow, UK (March 2017) | Conference report available in CCI
- Annual DIA EuroMeeting, Hamburg, Germany (March 2016) | Conference report available in CCI
- Annual DIA EuroMeeting, Vienna, Austria (March 2014) | Conference report available in CCI
- Annual TOPRA Symposium, Lisbon, Portugal (October 2013) | Conference report available in CCI
- Annual DIA EuroMeeting, Monaco (March 2010) | Poster presenter | Comparison between the EU and US regulatory frameworks surrounding somatic cell therapy, gene therapy and tissue engineered products
- Annual DIA EuroMeeting, Barcelona, Spain (March 2008) | Poster presenter | Medicines and Borderline Products
Sergio Held
Managing Editor
Regulatory Intelligence
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Sergio Held is Managing Editor, responsible for the regulatory intelligence of Latin America. He joined the regulatory intelligence team in Barcelona in 2016, after working for two and a half years as a staff writer covering the LatAm region for BioWorld Today and Medical Device Daily, based out of Bogota, Colombia, where he is recognized also as an investigative journalist and on-air radio talent.
Sergio graduated as a lawyer from Universidad de los Andes (Bogota, Colombia) and holds a master in Journalism from the University of Hong Kong. He speaks Spanish, German and English and understands Portuguese.
His legal expertise and journalistic background have led Sergio to different positions, mostly in the media. Sergio´s journalistic work has been featured in CNN en Español, Deutsche Welle, Asian Legal Business (Thomson Reuters), India Business Law Journal, China Daily Asia, the World Bank, RCN Radio (Colombia), Channel News Asia, OZY.com, among other media outlets, many of them, served by Bahati, a Hong Kong-based company that provides editorial content to the media around the world.
During his time in Hong Kong, Sergio became fascinated by public health issues. He attended online courses offered by USAID and the Johns Hopkins Bloomberg School of Public Health and during his professional career, he has attended the three editions of BIO Latin America, organized by BIO in Rio de Janeiro and Sao Paulo, Brazil, as well as national medical devices congresses in Colombia, and the HOSPITALAR fair, the largest med-tech event in Latin America, that takes place every year in Sao Paulo, Brazil.
Céline Rodier Seguy
Pharm D, Manager
Regulatory Services
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Céline Rodier Seguy has 10 year experience in Regulatory Affairs and Regulatory Intelligence and over 7 years across hospital, clinical research and pharmacy. She started as Regulatory Solutions Consultant in Life Science Professional Services in 2013 and since then has developed the Regulatory Services offering and team of Analysts. She joined Thomson Reuters in 2010 as Managing Editor for Northern EU modules of Cortellis Regulatory Intelligence database. Before that was a Regulatory Affairs Pharmacist Associate at Laboratoires Cyclopharma (Radiopharmaceutics) where she was in charge of various national and European applications (for drugs, medical devices and facilities), review of safety cases , advertising control, pharmacists' registration, setting electronic submission and promotion control activities. She could experience various audits from drugs and nuclear authorities. PharmD, her background includes 4 year Post Graduate, development of Quality Assurance for clinical trials management across different structures of public research, medical devices and chemotherapies manufacturing.
Céline is a member of TOPRA and participates to TOPRA in France and TOPRA RI Spin workshops.
She has made interventions at international conferences and contributed to the following thought leadership activities:
- MEDICAL DEVICES IN JAPAN: REGULATORY OUTLOOK FOR 2017 (2016)
- The Five Competencies of Continuous Regulatory Compliance (2016)
- Annual TOPRA Symposium, Lisbon, Portugal (October 2013)
Jianhui Zheng
Managing Editor
Canada, China, India, Indonesia, Philippines, Taiwan and Vietnam
More information about Jianhui Zheng
Jianhui Zheng is Managing Editor, responsible for the regulatory intelligence of Canada, China, India, Indonesia, Philippines, Taiwan and Vietnam. She joined Thomson Reuters in 2013.
She holds a master degree in Regulatory Affairs from Paris XI University (France), and also has a French Post-bachelor degree in Marketing after University Diploma of literature in China.
Before joining Thomson Reuters, Jianhui worked many years in Regulatory Affairs within global pharmaceutical companies for new registration, MA maintenance and other RA projects such as manufacturing site transfer, authorities’ on-site inspections and labelling coordination especially for emerging countries of Asia, Middle East and Africa.
She contributed to the following thought leadership activities:
https://fr.linkedin.com/in/jianhui-sun-23136a6
