Amplexor Life Sciences to exhibit at forthcoming Indian Pharma Regulatory Summit 2023

Amplexor Life Sciences to exhibit at forthcoming Indian Pharma Regulatory Summit 2023

We will be exhibiting at this year’s Pharma Regulatory Summit 2023. Amplexor executives will be on hand to discuss some of the Indian industry’s latest developments.

The sixth Annual Pharma Regulatory Summit 2023 brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches and solutions that will drive innovation and quality for medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply innovative solutions in today’s global regulatory environment.

The event will feature a range of key themes to be discussed, including Indian pharma regulations; regulatory compliance; remote clinical development; prioritizing patient safety; medical devices; and Indian product registration.

“The Indian market is currently the source of much attention so we are naturally delighted to join this exciting event to explore all the market has to offer,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “Please come and visit our experienced team to find out what services and products we currently offer in India and how we can help your business thrive.”

The event takes place on 28th March at the Hotel Kohinoor Continental, Mumbai, India. If you would like to register for the meeting with our representatives at Indian Pharma Regulatory Summit 2023, please fill out this form.

 

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Amplexor Life Sciences to exhibit at forthcoming DIA Europe 2023

Amplexor Life Sciences to exhibit at forthcoming DIA Europe 2023

Amplexor Life Sciences to exhibit at forthcoming DIA Europe 2023

We will be exhibiting at this year’s DIA Europe 2023. Senior Amplexor executives will be available to discuss some of the industry’s most important trends.

For 35 years, DIA Europe has been the largest neutral event in the European life science industry – the knowledge hub between science, healthcare, and regulation – and the place to meet trusted colleagues and make new connections with the brightest minds who are passionate about advancing health priorities.

The event features four tracks: Artificial Intelligence and Data Science; EU Health Policy and Regulatory Strategy; Medical Devices and Combination Products; and Professional Development. Sessions are designed to drive insights into action by connecting key policy discussions to real-world knowledge that delegates need for their everyday job.

“We are always delighted to bring Amplexor Life Sciences to DIA Europe, and this year is no exception,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “We gladly invite all delegates to pay us a visit at Booth 32, where our knowledgeable subject experts will be on hand to address the industry’s most pressing questions.”

The event takes place on 22-24 March at the Basel Congress Center. The Amplexor Life Sciences team can be found at Booth 32. Please fill out this form to book a meeting with our industry experts.

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Visit us at DIA North Bethesda

Visit us at DIA North Bethesda

Visit us at DIA North Bethesda

We will be exhibiting at the this year’s DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum. Senior Amplexor executives will be available to explore some of the industry’s most pressing questions.

The Forum features four tracks: Regulatory Informatics, Trial Master File (TMF) Inspection Readiness and Electronic Document Management (EDM), and Electronic Regulatory Submissions (ERS). Cross-track sessions will allow the discussion of key connections across major components of regulatory information, while daily plenary sessions will showcase regulatory intelligence updates by FDA and other regulatory authorities.

The RSIDM Forum will also provide multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees. Together, they will debate the scope of regulatory information when it comes to evolving data standards as well as the effective regulatory information management approaches needed to align related people, processes, and technology.

“We are delighted to bring Amplexor Life Sciences to the Forum in person where our experienced subject experts will be on hand to discuss the latest industry trends,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “We would invite anyone who would like to explore the implications of Regulatory Informatics, EDM and TMF, and ERS in the context of current industry trends to visit us at Booth 205.”

The event takes place on 13-15 February at the Bethesda North Marriott Hotel and Conference Center in North Bethesda, Maryland. The Amplexor Life Sciences team can be found at Booth 205. 

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Can’t Stop the Audit Trail!

Can’t Stop the Audit Trail!

WEBINAR ON DEMAND

Can’t Stop the Audit Trail!

In this webinar you will learn:

  • What is audit trail, and why would you need one?
  • Why is it important for businesses to maintain a comprehensive and complete audit trail
  • What are the audit trail benefits which go beyond compliance
  • How does audit trail look in practice

The webinar will conclude with a demonstration of the AMPLEXOR Life Sciences Suite and its audit trail 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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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 TOPRA 2022

Visit us at TOPRA 2022

Visit us at TOPRA 2022

We will exhibit at the forthcoming TOPRA Annual Symposium in Vienna on 17-19 October. The Symposium, which encompasses human pharmaceuticals, medical devices/IVDs and veterinary medicines, brings together key regulatory professionals from big pharma, small and medium-sized enterprises, regulatory agencies, biotech, service providers, consultants, academia, patient groups and legal services.

The Symposium, held yearly since 2004, is the premier conference in Europe dedicated to healthcare regulatory affairs, with a programme encompassing the topics most relevant to those working in healthcare regulatory affairs, whether for human or veterinary medicines, medical devices or IVDs. The conference also includes a one-day session devoted to regulatory affairs related topics of particular interest to those working for start-ups, at SMEs and in academia.

The Symposium is open to anyone interested in regulatory affairs and gathers delegates, speakers and exhibitors from industry, regulatory bodies, support services (consultants, recruiters, translators) and connected areas (patient groups, charities, healthcare professions, legal firms, universities, notified bodies and the media).

 

“TOPRA helps our customers to access the latest information and insights while networking with thought leaders in healthcare,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “Our presence at both events will allow our customers to get up to date with our product news, including the latest releases and updates.”

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