Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from pharmaceutical industry involved in:
3rd Annual Pharmaceutical Regulatory Affairs Summit
10 - 11 May 2023 | InterContinental Vienna
PAST SPEAKERS
SEE THE PREVIOUS SPEAKERS & CASE STUDIES
Iivi Ammon
Head of Regulatory Affairs, Baltic countries
Mónica Perea Vélez
CMC Advocacy and Policy Director
Caroline Petit
International Advertising and Promotions Lead, Associate Director, Global Regulatory Affairs
Elvira Falco
Licence to Operate Head (SPAIN)
Luana Riccardi
Regulatory Strategy Associate Director
CONFERENCE TOPICS 2023
LOOK AT THE TOPICS THAT WERE DISCUSSED
- Overview of the legislative and non-legislative actions within the new EU pharmaceutical strategy
- A balance between affordable access to medicines and preserving incentives for innovation
- Advantages of blockchain technology implementation in your RA strategy
- AI technology as a way to analyse patterns in data sets to help understand the implications, benefits and success rates of new drugs before launching them
- Big data analytics: High-performance systems to analyse the volumes of data generated during the drug discovery
- EU novel strategies for safe and affordable medicines
- What are the general obligations of the clinical trials regulation with regard to personal data?
- Blockchain technology as a tool to stop the usage of counterfeit medicines and substandard drugs
Designed for
- Regulatory Affairs
- Regulatory Intelligence
- Regulatory Policy
- Regulatory Compliance
- Regulatory Operations
- Regulatory Project Management
- Regulatory Information Management
- Regulatory Devices
- Regulatory Strategy
- Regulatory Submission
- Regulatory Sciences
- Regulatory Documentation
- Regulatory Labelling
- Regulatory Development
- Data Collection
- Data Management
- Lifecycle Management
- Regulatory Writing
- Scientific Affairs
Gargi Banerjee
Head- Talent, Learning & Organisation Development
Julphar
CASE STUDY
HR Transformation: An Organisation Value Driver
HR transformation as an HR function that reflects and supports the broader organisation and its strategic objectives.
- What is HR transformation – Inside out & Outside in
- What does business expect from HR?
- How HR can bring value to the business and employees at large?
- Broad understanding of “Organisation Grading Framework”
- Job Evaluation Matrix
CASE STUDY
Paperless PIL Packs - Piloting Across Borders
On 14 Oct 2020, NHAs of Estonia, Latvia and Lithuania held a common meeting, where industry associations from all concerned countries applied for presenting their proposals to increase the availability of medicines. One of the proposals was to run a pilot project to skip paper-PIL from packs of hospital products. A pilot has been running since 1 Jan 2022, and while looking at various milestones, we take a look also at future perspectives.
The presentation will dive into a roadmap of the ongoing pilot project in the Baltic countries, focusing on:
- Background and legal basis
- Purpose and scope
- Future perspectives
Iivi Ammon
Head of Regulatory Affairs, Baltic countries
Bayer
Luana Riccardi
Regulatory Strategy Associate Director
Vertex Pharmaceuticals
CASE STUDY
RWE and Regulatory
The observation of data from the normal clinical practice is an important point for the safety and efficacy of the drugs on the market. The RA role in the process and the collaboration with other departments like Medical and Market Access is fundamental.
- What is RWE?
- Regulatory framework
- Cross-functional collaboration
- Use of RWE
CASE STUDY
Regulatory Strategies for Rapid Development and Commercialisation of COVID mAb Therapies
The speaker will discuss how principles for development of all products for unmet medical need, encapsulated in EFPIA publications and the EMA PRIME Quality toolbox were used to expedite development of mAb therapies, and the challenges of applying these strategies to therapies for the treatment of COVID-19. Use of interim specifications with commitments to update at later stage, use of in vitro potency assays, flexibility on importation testing, use of investigational material for “early commercial” product supply, method qualification based on benefit-risk, staggered submission of data e.g., process validation provided at later stages in the review and use of stability data from non-clonal cell line materials to justify shelf life of monoclonal commercial product will also be presented.
- Present strategies to accelerate development and commercialization of mAb therapies under a pandemic setting.
- Highlight the importance to build on COVID-19 learnings with regards to rapid access of products for unmet medical need to patients.
Mónica Perea Vélez
CMC Advocacy and Policy Director
GSK
CASE STUDY
Challenges and Opportunities in the Next Years for Regulatory Affairs, the Affiliate Perspective
It is well known that the regulatory framework will suffer in EU a profound change in the coming years, derived from the European Commission (EC) legal proposals for the revision of the general pharmaceutical legislation, orphan and paediatric regulations, as well as the implementation of the Regulation on health technology assessment, and In Vitro Devices and Medical Devices regulations. These regulatory changes will surely require affiliates engagement and support since most of the changes will require national set up, and most probably, many EU authorities will develop guidances.
- Review of the new regulatory trends and local impact
- Global and local interactions: How we do shape the national eco-systems?
- How to ensure compliance and being efficient in an increasingly complex regulatory environment?
Elvira Falco
Licence to Operate Head (SPAIN)
Roche Farma, S.A. SPAIN
STAY UPDATED FOR THE 2024 EDITION
Provide Us With Your Contact Details and Our Team Will Get Back to You With All the Updates Regarding the Upcoming Edition of This Event.
