Events

TOPRA ANNUAL SYMPOSIUM 2015 – BERLIN: REGULATORY PHARMA NET MANAGING DIRECTOR, ANITA FALEZZA, INTERVIEWED

TOPRA’s Annual Symposia – covering pharmaceuticals, veterinary medicines and medical devices – are together the largest forum for European regulatory professionals to meet up, discuss current regulatory issues and debate future plans for regulation.

From 12th till 14th of October RPN exhibited at the TOPRA Annual Symposium held in Berlin at the Maritim ProArte Hotel.

You warmly welcomed many attendees at the booth and discussed new exciting projects and potential future collaborations.
If you didn't manage to talk to us, please contact Dr. Anita Falezza to: a.falezza@regulatorypharmanet.com

During the Symposium, participants had the opportunity to discuss and understand proposed regulations and other issues affecting the regulatory roles.

Topics discussed included the following:

  • Accelerating drug development – What is the regulatory role in delivering medicines more quickly to patients?
  • Implementation of the new clinical trials Regulation – Are we on the right track?
  • Scientific (regulatory) advice and HTA advice – How best to talk to each other
  • Globalisation of pharmaceutical regulation – What do agencies discuss behind closed doors?
  • Mutual recognition/decentralised procedure (MRP/DCP) – What is working well and what challenges remain?
  • Drug-Device Combination Products – Regulatory challenges and importance of usability and human factors considerations
  • Biosimilar medicines
  • The Pharmacovigilance Regulation – 3 years into implementation: challenges and opportunities
  • Availability of medicines – How do new medicines impact the supply of established and essential medicines?
  • The New EU Device Regulations – Impact on Notified Bodies and industry
  • Software as a medical device
  • Vigilance
  • Clinical evaluations and clinical investigations

Our Managing Director, Dr. Anita Falezza was also interviewed during the meeting.

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News

REGULATORY PHARMA NET AWARDED RENEWAL AND EXTENSION OF ISO 9001:2008 CERTIFICATION

Regulatory Pharma Net has just obtained the renewal of the UNI EN ISO 9001:2008 certification for the quality management system and the extension of the certification to all services offered to the clients.

The updated UNI EN ISO 9001:2008 certificates are available here.

The Certification Body Certiquality is member of IQNet, the International Certification Network, which brings together the most prestigious certification organizations of 36 countries and ensures mutual recognition of the certificates issued.

This achievement is one we are particularly proud of as it demonstrates our commitment to provide the highest quality services to our clients and further establishes Regulatory Pharma Net as a qualified partner for the management of regulatory affairs including drug development and of pharmacovigilance, clinical trial authorisation, medical information and market access activities.

The certification is also a significant milestone in our continuous efforts to improve our internal processes with the aim to provide consistent quality in the services that we deliver every day to our clients.

Producing quality work is a key priority for us at Regulatory Pharma Net. The ISO accreditation shows just a piece of work to ensure the best quality of services for all of our clients and we are proud of what we have achieved.