Breaking Down The Silos: First Step Towards Fruitful Collaboration

On the 10^th of October the top industry professionals gathered in Madrid, Spain, for Regulatory Day, an immersive workshop organized by Arithmos in collaboration with its partners Oracle Health Sciences and Asphalion.

The event, entitled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” brought together the best regulatory, QA, clinical, and pharmacovigilance specialists to discuss how they can collaborate to make the product development journey through post-marketing as efficient as possible both in EMA and FDA regulatory environments.

The Regulatory Day agenda was divided into three sessions, each of them dedicated to a different aspect of product development:

Session #1 Comparison of EMA and FDA Regulatory Landscape in Clinical Trials

• Introduction to FDA and EU Regulatory Activities for Drug Development and Clinical Trials – Lidia Canovas (Asphalion) and Bruce Thompson (Reguliance);
• Integrated Summaries: Strategies for Meeting Regulatory Challenges Faced by Sponsors – Marta Zanus (CROS NT);
• Pre-Marketing Safety Reporting & Signal Detection – Una Kessi (Oracle Health Sciences);

Session #2 Post-Market Regulatory

• Comparison of US vs EU Regulations, Procedures, Requirements, Practical Examples and Submission Format – Lidia Canovas (Asphalion) and Bruce Thompson (Reguliance);
• Surveillance and Safety Obligations after Approval – Una Kessi (Oracle Health Sciences);
• Post-authorisation Studies in the EU: PASS and PAES – Stefania De Santis (seQure);

Session #3 Impact of Technology on Regulatory and Vice Versa

• The (R)evolution of Technology in the Pharmaceutical Sector – Marcos Fernàndez Gómez (Asphalion);
• Digital Transformation in Clinical Trials: eClinical Selection and the Regulatory Impact – Silvia Gabanti (Arithmos);
• How AI and Cloud are Impacting Multivigilance – Michael Braun-Boghos (Oracle Health Sciences);

Silvia Gabanti, Arithmos Managing Director, at Regulatory Day

Roundtable discussions

The final part of Regulatory Day engaged the event guests in the roundtable discussions on where the market is moving and invited them to share their own experience in breaking down the silos between departments in their companies.

• Roundtable #1: Regulatory Challenges in the Industry: EU vs FDA, Brexit, and IDMP
• Roundtable #2: Breaking Down the Silos between Regulatory Affairs, Safety, and Clinical R&D

Breaking Down the Silos: Complexities and Benefits

The information flow between various departments involved in medicinal product development is not always straightforward, especially when it comes to large companies. Due to the structural obstacles and lack of time caused by pressing deadlines regulatory, clinical, and safety professionals might not fully comprehend the work done by other departments.

Collaboration and continuous information exchange between different professionals that work either in EMA or FDA environment favour the acceleration of product development and increase efficiency. Regulatory Day gave participants a sneak peek into the work of their colleagues and challenges they face, inviting them to explore new ways of collaboration.

Interested in other Arithmos events?

• ACDM: New Era of Data Management
• Workshop: Industry 4.0 and Life Sciences
• Summary: conference “Artificial Intelligence and Clinical Research” (Milan) | What is the industry saying?

PM Holding Appoints Angela Weston as Chief Commercial Officer

Verona, Italy (11 September 2019) – PM Holding, a group of diverse service providers in the life sciences industry, announces the appointment of Angela Weston as Chief Commercial Officer to manage business development operations across the entire group.

PM Holding consists of specialized service providers in the drug and device development sector including:

• CROS NT (global, expert biometrics CRO);
• Arithmos (technology solution provider and system integrator);
• seQure Life Sciences (niche provider of vigilance, quality assurance and regulatory services).

Angela brings a wealth of experience in business development, marketing and product management roles at a global level for multinational companies in the pharmaceutical, medical device and CRO environments. She started her career in Nursing moving into sales with B.Braun and Boston Scientific, she later moved into the CRO sector with Premier Research Group, Aptiv Solutions (ICON plc) and Inventiv Health (Syneos Health). Angela has an impressive track record of implementing strategies to support global sales, marketing and proposal management with a thorough understanding of our industry and client needs.

The decision to hire a CCO comes at time when the PM Holding group of companies are expanding globally and offering more comprehensive services to the market especially in the area of digital health.

Paolo Morelli, CEO and Owner of PM Holding, said, “we are at a crucial, yet exciting, phase in PM Holding where we are developing new solutions to meet market demands in data science, digital health and overall oversight and quality in clinical trials. It’s a collaborative effort, and I am confident that Angela’s experience and industry knowledge will help us identify our key markets, positioning and message. Her success in implementing successful business development and marketing infrastructure and strategies to enable company growth speaks for itself”.

Angela commented, “for the past several years I have supported companies to develop value generation strategies, and therefore I see PM Holding as a great opportunity and fit for me. The companies under the PMH brand have huge potential both individually and collectively to offer impeccable quality services and innovative solutions to our clients in the global marketplace and I am excited to be part of this growth phase”.

Angela is based in Europe.

PM Holding Announces Joint Regulatory Day Event in Partnership with Oracle and Asphalion

Event titled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” will take place in Madrid on the 10^th October

The PM Holding group of companies including CROS NT, Arithmos, and seQure are excited to announce a Regulatory Day workshop, a unique event in collaboration with Oracle and Asphalion that focuses on the product development journey through post-marketing, and compares the FDA and EMA regulatory landscapes. The workshop aims to not only provide expert sessions on pre- and post-market regulatory topics, but also engage stakeholders, KOLs and industry professionals in the discussion on where the market is moving.

Organizers

Who is hosting this event? A group of international companies specialized in life sciences, healthcare and clinical research with solid experience in the regulatory field and direct contact with European and American regulatory authorities.

• • PM Holding is a group of companies providing an end-to-end service of added value to clinical research through:
    • CROS NT: biometrics specialized CRO
    • seQure: Safety, QA and Regulatory experts;
    • Arithmos, innovative technology and solutions;
• Oracle is the #1 provider of business software, with a broad portfolio of solutions for companies of all sizes. It boasts 430,000 customers in 175 countries.
• Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Amsterdam, and Munich. It provides worldwide support, offering services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.

Agenda

The focus of Regulatory Day is “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” and the speakers will guide the participants through the labyrinth of European and American regulations, procedures, requirements, and submission format.

The event agenda features the following topics:

• Integrated summaries;
• Pre- and post-market safety;
• Digital Transformation in Clinical Trials.

The detailed agenda can be downloaded here.

Logistics

The immersive event will take place on the 10^th of October at the Oracle office in Madrid, capital of Spain and a centrally located city strategically situated near important pharmaceutical and biotech hubs.

The event participants can reach the venue from the center of the city by metro or by taxi.

Registration

The participation in the event is free of charge and can be done following this link.

Every pass includes:

• Participation in scientific sessions;
• Participation in the roundtable discussionsr;
• Coffee breaks and lunch;
• Access to the presentation material post-event.

Questions?

In case of questions, get in touch with us via email at info@arithmostech.com.

Interested in more Arithmos updates?

• ACDM: New Era of Data Management
• Summary: conference “Artificial Intelligence and Clinical Research” (Milan) | What is the industry saying?
• Workshop: Industry 4.0 and Life Sciences