Visit us at the 2nd Pharmaceutical Regulatory Affairs Summit

Visit us at the 2nd Pharmaceutical Regulatory Affairs Summit

We will exhibit at the forthcoming 2nd Pharmaceutical Regulatory Affairs Summit, which will be held in Vienna on 26-27 October. The Summit is designed to explore the most interesting regulatory topics of 2022, including regulatory status during COVID-19, decentralised Clinical Trials, new professional strategies in 2022, statistic of data in regulatory daily basis, hot issues in pharmaceutical regulatory industry and many others.  

We will also present on: “5 essential IDMP readiness checkpoints for your future-proof RIM platform”. Other topics to be explored during the Summit include: 

  • Company’s sustainability commitment: What priorities should be on the top of regulatory affairs’ agenda? 
  • COVID-19 vaccines and treatments: Why is it important for regulators to have further discussions in regulatory forums for being in “harmony” with pandemic consequences? 
  • How to simplify work: Collecting, collating and evaluating scientific data? 
  • Regulatory labelling challenges: Communicating proper use and risk of a medicine by both the summary of product characteristics and product license 
  • Global public health emergency scenario: Why is it important to expedite regulatory steps? 
  • Collaboration with regulatory authorities: How to secure early engagement and dialogue? 
  • An overview on growing demand of new professional strategies in 2022 
  • How are strong results from regulatory approvals changing therapies for disease, while weaker results may dull hope and shut testing down? 
  • Machine learning (ML): Building algorithm to make accurate prediction and act 

 

“The 2nd Pharmaceutical Regulatory Affairs Summit is an opportunity to discuss some of the more pressing challenges facing our industry,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “That’s why we are delighted to provide a presentation based on our deep expertise in the field of IDMP.” 

 

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Visit us at RAPS Convergence 2022

Visit us at RAPS Convergence 2022

Visit us at RAPS Convergence 2022

RAPS Convergence 2022 returns in-person, bringing industry professionals and regulators together to co-create, problem-solve and discuss global and local challenges facing professionals in the regulatory life sciences community.

It will be thrilling to return to a face to face gathering of such prestigious individuals and companies in Phoenix from September 11-13. This is a great opportunity to take stock of the impact of the past few years and take the pulse of the wider life sciences industry.

The Amplexor Life Sciences team can be found at Booth 612. If you would like to schedule a meeting with us at RAPS Convergence 2022, please fill out this form. 

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How to demonstrate a risk-based and effective Change Management system?

How to demonstrate a risk-based and effective Change Management system?

WEBINAR ON DEMAND

How to demonstrate a risk-based and effective Change Management system

In pharmaceutical industry, every change is reported through change management process.

In this webinar you will learn when the concept behind change management began to form, how a good change management system might benefit your business and receive some guidance on evaluating and demonstrating the effectiveness of a risk-based change management system.

The webinar will conclude with a demonstration of the AMPLEXOR Life Sciences Suite and its change management capabilities.

About the speakers
Vanja Primorac

Vanja Primorac

ALSS Business Consultant

As a Life Sciences Consultant, Vanja is responsible for the contribution to the development and enhancement of the Amplexor Life Sciences Suite, as well as the provision of business process and data management expertise to Amplexor clients in the area of Quality Assurance.

Before joining Amplexor, Vanja worked in GlaxoSmithKline, where she was holding the position of Senior Quality Executive and Responsible Person.

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Be The Expert Day 3

Be The Expert Day 3

ONLINE EVENT ON DEMAND

Be The Expert 2022

Day 3 Presentations

Amplexor Life Science’s conference Be The Expert brings together leading subject matter experts and industry professionals from around the world into one forum to discuss and exchange strategies that combat challenges confronting the Life Sciences industries.

 

Watch the presentations from Be The Expert 2022 Day 3 virtual event.

About the video

Video recording from Day 3 Be The Expert 2022 virtual conference featuring:

1. Danijel Saifert, Amplexor Life Sciences: The impact of SaaS on the Pharmaceutical industry – to Cloud or not to Cloud?

2. Thierry Dietrich, Pharm@dviser: Ensuring data integrity and computerized system validation in the cloud

3. Vanja Primorac, Amplexor Life Sciences: Grab your business by the KPIs!

About the speakers
Danijel Saifert

Danijel Saifert

Senior Manager Strategic Accounts, Amplexor Life Sciences

Danijel Saifert is Senior Manager for Strategic Accounts in Amplexor Lifescience. He is the holder of numerous technical certificates and scientific papers

on the topic of distribution computer systems and cloud. He has more than 10 years of experience in Managed services and Cloud infrastructure and SaaS, PaaS and IaaS.

He has built his career in companies such as ATOS and Samsung.

Dr. Thierry Dietrich

Dr. Thierry Dietrich

Founder at pharm@dviser

Dr. Thierry Dietrich serves in leading and consulting positions within the pharmaceutical and medical devices industries for more than 20 years. He founded pharm@dviser in 2016, and acts as management consultant.

His areas of focus are data integrity auditing, auditing of IT suppliers and IT organizations, leading of large IT projects in GxP regulated areas, validation of computerized systems, as well as the building and optimization of quality management systems with focus on IT and data quality.

Thierry Dietrich was/is leader resp. member of several GAMP® SIGs and ISPE. He also is the author of numerous technical publications, co-author on data integrity related books, and speaker on technical conferences. He received his PhD in natural sciences and master degree in chemistry from Johann Wolfgang Goethe University Frankfurt.

Vanja Primorac

Vanja Primorac

Life Sciences Consultant, Amplexor Life Sciences

As a Life Sciences Consultant, Vanja is responsible for the contribution to the development and enhancement of the Amplexor Life Sciences Suite, as well as the provision of business process and data management expertise to Amplexor clients in the area of Quality Assurance.

Before joining Amplexor, Vanja worked in GlaxoSmithKline, where she was holding the position of Senior Quality Executive and Responsible Person.

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Be The Expert Day 2

Be The Expert Day 2

ONLINE EVENT ON DEMAND

Be The Expert 2022

Day 2 Presentations

Amplexor Life Science’s conference Be The Expert brings together leading subject matter experts and industry professionals from around the world into one forum to discuss and exchange strategies that combat challenges confronting the Life Sciences industries.

 

Watch the presentations from Be The Expert 2022 Day 2 virtual event.

About the video

Video recording from Day 2 Be The Expert 2022 virtual conference featuring:

1. Tris Nockels, IRSS Forum/Navitas: The future of labeling – a digital reality?

2. Remco Munnik/Dennis Verhaegh, IPERION: Streamline IDMP data in your RIMs to accelerate your eSubmissions and labeling

3. Renato Rjavec, Amplexor Life Sciences: Electronic submissions in the data-driven regulatory operations

About the speakers
Tris Nockles

Tris Nockles

Regulatory Industry Thought Lead at Navitas

Tris Nockles has been leading the Navitas Regulatory Industry Networks for the last two years, with 18+ years of industry exp in Life Sciences, Devices & Consumer Products. She specializes in strategy, process improvement and development initiatives focusing on Regulatory, E2E labeling & RIM. Tris is located in the UK, and is fortunate to live near the coast where she loves to walk on the beach with her partner and her three dogs.

Remco Munnik

Remco Munnik

Director at Iperion

Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP.
Remco is also an active member of EMA ISO IDMP Task Force Organizations and Products; Chair of Medicines for Europe Telematics group; and Vice-President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals. One of Iperion’s widely-acknowledged strengths is its deep networking with stakeholders across life sciences – including regulators, software vendors and customer groups.

Renato Rjavec

Renato Rjavec

Director of Products, Amplexor Life Sciences

As Director of Products, Renato is responsible for Amplexor’s Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

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