EVENT – The World Drug Safety Congress Europe 2022 | Amsterdam, NL

The World Drug Safety Congress Europe empowers patients, physicians, pharma, biotech, and consumers to make the best drug safety decisions. This year it will bring together 600+ key thought leaders to explore new challenges within pharmacovigilance, like the use of big data and AI in pharmacovigilance, benefit-risk management strategies examination, and patient-centric approaches. They will also discuss how to tackle the challenges of social media and drug safety legislation globally.

Our PrimeVigilance team will be exhibiting for three days in Amsterdam for the most comprehensive program and inclusive gathering of pharmacovigilance stakeholders.
If attending, we encourage you to listen to PrimeVigilance Director of Medical Writing, Dr. Vjera Bilušić Vundać, invited as a speaker on the topic “Risk Management Plan” scheduled for Sep 27 at 17:10.

 


Dr. Vjera Bilušić Vundać
Director of Medical Writing, PrimeVigilance

We also invite you to visit our booth #53 to meet our experts and commercial team.


Sally Amanuel
President, PrimeVigilance


Alessandro Di Ranno
Vice President, Business Development Europe
alessandro.diranno@ergomedplc.com


Aleksander Borkowski
Business Development Manager, PrimeVigilance
aleksander.borkowski@ergomedplc.com

For more information about this event, please visit https://www.terrapinn.com/conference/world-drug-safety-congress-europe/index.stm 

If you have any questions or want to set up a meeting with the PrimeVigilance team during the The World Drug Safety Congress Europe, you can email us at marketing@ergomedplc.com.

We look forward to seeing you there!

NEWS – Pharmacovigilance Inpections and Audits Navigation webinar series continues

Pharmacovigilance Inspections and Audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

This webinar will provide guidance on the planning, conduct, reporting, and follow-up of pharmacovigilance (PV) inspections and audits in the EU from the perspective of the inspector or auditor. You will gain insight into the regulatory framework as well as into the concept of inspection and audit from the inspector/auditor perspective. The webinar will also contain examples of inspection/audit findings that might help you to fix potential gaps in your PV system.

Choose between one of 3 sessions available for this webinar on July 28th:
  • Session 1: 28 Jul, 6am EDT / 11am BST / 12pm CEST
  • Session 2: 28 Jul, 10am EDT / 3pm BST / 4pm CEST
  • Session 3: 28 Jul, 2pm EDT / 7pm BST / 8pm CEST
Agenda:
  • Regulatory framework applicable to PV Inspections and Audits
  • PV Inspection Readiness from inspector perspective
  • PV Audit Readiness from auditor perspective
  • Examples of Inspection/Audit findings

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

 

About our expert speakers:

Jana Hyankova, MD
Senior PV Director, EU QPPV, UK QPPV


Jana Hyankova is an expert on pharmacovigilance with more than 15 years of working experience from several global pharma companies. Jana joined PrimeVigilance (former PharmInvent) in 2014 and currently holds the position of Senior PV Director in the QPPV Department. She serves as EU QPPV and UK QPPV for several clients and conducts PV audits as requested by clients. Prior to joining PrimeVigilance, she held managerial pharmacovigilance roles at Bristol Myers Squibb and PharmaSwiss SA after acquisition of the company Valeant Pharmaceutical International. Jana has gained her medical education at Charles University in Prague. Outside of PrimeVigilance, Jana is chairing RQA Pharmacovigilance Committee and is also an active lecturer of the RQA, PIPA, ISoP, and Conforum.

 

Zuzana Chomatova
Senior Strategic Advisor, EU QPPV, UK QPPV


Zuzana Chomatova is a professional with 14 years of experience in pharmacovigilance gained in regulatory agencies and the pharmaceutical industry. Zuzana is currently working in PrimeVigilance in the position of Senior Strategic Advisor for pharmacovigilance. Zuzana serves as the EU QPPV and the UK QPPV for several clients (MAHs). Prior to joining PrimeVigilance in 2019, Zuzana as the pharmacovigilance inspector at the Czech national agency, built up the procedure for conducting pharmacovigilance inspections and completed a large number of inspections (according to the national inspection programme as well as the EMA inspection programme for CAPs, all of them as a Lead inspector). As a member of the Pharmacovigilance Inspectors Working Group under EMA, she participated in the development of European Pharmacovigilance Guidelines (GVP), Union Procedures on EU pharmacovigilance inspections, and other documents or opinions. Zuzana is also occasionally leading PV audits and gap analysis of PV Systems of the clients and providing PV trainings internally and externally.

 

If you have any questions about our webinar please feel free to contact us 

EVENT – DIA Global Annual Meeting 2022 | Chicago, IL

PrimeVigilance will be exhibiting so please visit us at our booth #B1231 to meet our team of experts and learn about our full range of top quality and innovative life-cycle management services in pharmacovigilance, medical information, regulatory science, and benefit-risk management.

PrimeVigilance, an Ergomed plc company, is a leading provider of global, high quality, and innovative pharmacovigilance services. Dedicated to providing pharmacovigilance services, PrimeVigilance covers the entire product life cycle, assisting clients with the effective management of their drug safety information, and offering expert consulting services from former regulators, inspectors, and PV opinion leaders.

With over 300 clients, PrimeVigilance is dedicated to delivering high-quality, fully compliant global life cycle management safety solutions.

 

Attending #DIAGlobalAnnualMeeting2022? Come Meet Us!

 


Sally Ama
nuel
President, PrimeVigilance

Luis Encarnacion
Vice President, Business Development
luis.encarnacion@primevigilance.com

Christopher Agresti
Director, Business Development
christopher.agresti@primevigilance.com
 

If you wish to set up a meeting with us during the event, please contact us at marketing@primevigilance.com.

 

About DIA Global Annual Meeting 2022

The DIA Global Annual Meeting 2022 returns in-person to bring industry, regulators, academics, and patients together to co-create, problem-solve, and discuss global and local challenges facing professionals in the life sciences community. This year, DIA is offering the Global Annual Meeting as an in-person event hosted in the dynamic city of Chicago.

To read more about DIA Global Annual Meeting 2022, please visit the DIA Website

 

We look forward to seeing you there!

NEWS – New EU Clinical Trials Regulation Webinar

This webinar aims to summarize the new EU Clinical Trial Regulation (CTR) 536/2014 changes, focusing on the safety aspects. We will guide you through the key differences between Directive 2001/20/EC and CTR, the transitional period specifics, an overview of the safety reporting framework, and how best to manage some of the challenges this new regulation may bring.

Choose between one of 3 sessions available for this webinar on April 14th:
  • Session 1: 14 Apr, 6am EST / 11am BST / 12pm CEST
  • Session 2: 14 Apr, 10am EST / 3pm BST / 4pm CEST
  • Session 3: 14 Apr, 2pm EST / 7pm BST / 8pm CEST
Who Should Attend:
  • Sponsors of Clinical Trials
  • Pharma professionals interested in all CTR safety aspects
Agenda:
  • Overview of the legislative background
  • Transitional period arrangements
  • Safety reporting to NCAs and ECs
  • Directive vs. Regulation on key safety aspects
  • Newly introduced obligations

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

 

About our Expert Speaker:

Sara Vodanovic
Associate Director of Regulatory Affairs, Intelligence and Analytics, PrimeVigilance

 

Sara is a pharmacovigilance regulatory intelligence expert with 8 years of experience in this area as well as experience in XEVMPD, EudraVigilance Registrations, and safety reporting. She and her team are responsible for developing and maintaining the corporate proprietary intelligence system, which now includes more than 150 countries. This system covers the safety reporting requirements associated with medicinal products in clinical trials, authorized for marketing or made available through special access programs.

 

Download PrimeVigilance Flyer “Are You Ready for EU Clinical Trials Regulation 536/2014 (CTR)?”

 

If you have any questions about our webinar please feel free to contact us.

EVENT – DIA EUROPE 2022 | Brussels, BE

PrimeVigilance will be exhibiting so please visit us at our booth #B03 to meet our team of experts and learn about our full range of top quality and innovative life-cycle management services in pharmacovigilance, medical information, regulatory science, and benefit-risk management.

PrimeVigilance, an Ergomed plc company, is a leading provider of global, high quality, and innovative pharmacovigilance services. Dedicated to providing pharmacovigilance services, PrimeVigilance covers the entire product life cycle, assisting clients with the effective management of their drug safety information, and offering expert consulting services from former regulators, inspectors, and PV opinion leaders.

From its operational hubs based in Europe, Japan, and the USA, PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.

Come Meet Us

 

 

Sally Amanuel
President, PrimeVigilance

 

Valerie Leray
Head of Global Project Management, PrimeVigilance

 

Aleksander Borkowski
Business Development Manager, PrimeVigilance
aleksander.borkowski@ergomedplc.com

 

 

Rada Gantly
Business Development Director, PrimeVigilance
rada.gantly@primevigilance.com

If you wish to set up a meeting with us during the event, please contact us at marketing@primevigilance.com.

 

About DIA EUROPE

DIA EUROPE is the largest neutral event in the life science industry in Europe – the knowledge hub between science, healthcare, and regulation – and the place to meet trusted colleagues and make new connections with the brightest minds passionate about advancing health priorities. This year, DIA Europe 2022 will be held from 29-31 March in Brussels, Belgium, and virtually (attendees only), with new session formats and enhanced opportunities to learn, connect, and collaborate with all stakeholders across the entire spectrum of the life science landscape.

To read more about the DIA EUROPE please visit the DIA Website.

 

We look forward to seeing you there!

PRESS RELEASE – Ergomed acquires ADAMAS, a leading global regulatory compliance provider

Ergomed plc Press Release

Guildford, UK – 9 February 2022: Ergomed plc (LSE: ERGO) (“Ergomed” or the “Group”), a company focused on providing specialised services to the pharmaceutical industry, today announces the acquisition of ADAMAS Consulting Group Limited (“ADAMAS”), an international specialist consultancy offering a full range of independent quality assurance services and specialising in the auditing of pharmaceutical manufacturing processes, as well as auditing clinical trials and pharmacovigilance systems. The acquisition has been completed for a cash consideration of £25.6 million, representing an enterprise value of £24.2m and cash acquired of £1.4 million, paid at completion. The transaction is expected to be immediately accretive to Ergomed’s future earnings, with further growth synergies and strategic benefits expected in future years.

Details of acquisition and strategic rationale

ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP). ADAMAS has a broad, established client base, with an expansive global reach, including the US, Europe and APAC, with over 100 currently active clients and having worked with over 700 pharmaceutical companies including 40 of the 50 largest global pharma and biotech companies.

ADAMAS will continue to operate as an independent consulting business following the acquisition. The existing senior executive team will continue in their current positions in the business, led by Ian Montague who will become President of ADAMAS Consulting, having been with the business for eight years and as Chief Executive Officer for the past three years. For reporting purposes, ADAMAS financial results will be allocated as appropriate across Ergomed’s existing businesses.

The acquisition aligns with Ergomed’s strategy to secure M&A transactions that further enhance the Group’s global presence and broaden the service offering to clients, whilst ensuring quality and compliance are central to its operational growth strategy. ADAMAS is focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector and the acquisition will therefore keep Ergomed at the forefront of specialist service provision.

Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: “This value-enhancing acquisition aligns with our disciplined M&A strategy, strengthening our position as a focussed premium pharmaceutical services business, whilst further building our Group’s scale in the strategically important US, Europe and APAC regions. With this deal we are addressing the pharmaceutical industry’s ever-growing need for best practice quality assurance due to the increasing complexity of drug development, pharmacovigilance and manufacturing processes and associated regulatory requirements. We look forward to working with Ian and the ADAMAS management team as we invest in and support this business to deliver a broader service offering to clients.”

 Ian Montague, Chief Executive Officer of ADAMAS, said: “Ergomed is a highly regarded business that shares our commitment to delivering regulatory compliance as well as the highest quality services to the global healthcare industry. Joining the Ergomed Group provides us with an even stronger platform and increased investment from which to grow our customer base, develop and scale up our offering and continue to deliver gold standard quality assurance services.”

 Dr Patricia Fitzgerald, Founder and Executive Chairman of ADAMAS, said: “ADAMAS has gone from strength to strength over the last 25 years and has established a global reputation for providing excellent research quality assurance services to the life sciences industry. ADAMAS has been successful in building an extensive and stable client base and has inspired a high level of trust and confidence with many long-term relationships. It has been an exciting and challenging journey and I know that ADAMAS, accelerated by strong support from Ergomed, will continue to grow and offer outstanding QA support to its clients worldwide.”

Acquisition terms and ADAMAS trading history

Under the terms of the purchase agreement, Ergomed has acquired ADAMAS for a cash consideration of £25.6 million, representing an enterprise value of £24.2m and cash acquired of £1.4 million, paid at completion. The acquisition will be wholly funded from the Group’s existing cash resources and bank facilities.

In its financial year ended 31 December 2021, ADAMAS recorded (unaudited) total revenues of £8.5 million, up 31% over 2020 total revenues, with adjusted EBITDA of £1.8 million.

Webcast and conference call for analysts:

 A webcast and conference call for analysts will be held today, 9 February 2022, at 10am GMT.

 Webcast link: https://www.lsegissuerservices.com/spark/Ergomed/events/7ef82c4e-0fb7-4506-a420-16d1e3150aac 

 Conference call registration: https://cossprereg.btci.com/prereg/key.process?key=PF7ULG6HM 

 A copy of the presentation will be made available on the Ergomed website before the webcast, under Reports and Presentations, here: https://www.ergomedplc.com/investor-relations/reports-and-presentations/ 

 The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014 as amended by The Market Abuse (Amendment) (EU Exit) Regulations 2019. On the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.

 ENDS

 

Enquiries:

Ergomed plc

 Tel: +44 (0) 1483 402 975

Miroslav Reljanović (Executive Chairman)

Richard Barfield (Chief Financial Officer)

Numis Securities Limited (Nominated Adviser and Joint Broker)

Tel: +44 (0) 20 7260 1000

Freddie Barnfield / Euan Brown (Nominated Adviser)

James Black (Broker)

 

Peel Hunt LLP (Joint Broker)

James Steel / Dr Christopher Golden                                 

 

 

Tel: +44 (0) 20 7418 8900

 

Consilium Strategic Communications – for UK enquiries

Tel: +44 (0) 20 3709 5700

Chris Gardner / Matthew Neal

ergomed@consilium-comms.com

/ Angela Gray

 About Ergomed plc

Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed brand (CRO). For further information, visit: http://ergomedplc.com.

  

NEWS – Pharmacovigilance Audits and Inspections Navigation New Webinar

Pharmacovigilance Audit and Inspections activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

To this end, pharmaceutical organizations must be able to provide evidence of strong standard operating procedures—on demand. Yet, even today, a majority of companies are still struggling to fulfill their obligations, potentially causing marketing authorization holders (MAHs) to fail inspections, incur fines, and see products withdrawn from markets.

This webinar will give you an insight into the readiness and management as well as practical tips of what works well and where the challenge may be as well as sharing real experiences.

Choose between one of 3 sessions available for this webinar on January 27th:
  • Session 1: 27 Jan, 6am EST / 11am GMT / 12pm CET
  • Session 2: 27 Jan, 10am EST / 3pm GMT / 4pm CET
  • Session 3: 27 Jan, 2pm EST / 7pm GMT / 8pm CET
Agenda:
  • Regulatory Framework Applicable to PV Inspections and Audits
  • PV Audits and Inspections Principles and Operational Differences
  • Pharmacovigilance Audit and Inspection Readiness from Auditee and Inspected Perspective
  • PV Audit and Inspection Follow-Up

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

 

About our expert speaker:

Tiago Barca Ramos
Associate Director of Projects and Qualified Person Responsible for Pharmacovigilance in the EU (EU QPPV), PrimeVigilance

 

Tiago is a qualified Pharmacist with deep knowledge of Pharmacovigilance legislation and over 10 years of experience in CRO on a global scale for large to mid-size as well as biotech pharma companies. In recent years, Tiago has been supporting pharma companies as a PV consulting Specialist and acting as global EU QPPV/ deputy or Local Contact Person for Pharmacovigilance in Portugal territory. Tiago has experience covering management of PV systems under QMS system (Gap Analysis, KPIs, SOPs, CAPA plans, vendor selection, and qualification), maintenance of PSMF, hosting audits and inspections, and performing internal and external PV audits. Tiago has successfully guided pharma companies through EU and MHRA inspections and, as an ISO certified auditor who performed several PV audits, Tiago is an expert in setting up and managing global pharmacovigilance systems while cultivating an excellent long-term relationship with clients.

 

If you have any questions about our webinar please feel free to contact us 

NEWS – Pharmacovigilance Advanced Learning New Webinar

Part of our “Pharmacovigilance Advanced Learning” webinar series, this new webinar aims for our experts to present and provide our listeners with a good understanding of Aggregate reports. Our webinar will guide you through Aggregate report types, planning, content, and current legal requirements, helping our listeners gain the knowledge and support in the preparation of Aggregate reports throughout the lifecycle of the medicinal product.

Choose between one of 3 sessions available for this webinar:
  • Session 1: 27 October, 6am EST / 11am GMT / 12pm CET
  • Session 2: 27 October, 10am EST / 3pm GMT / 4pm CET
  • Session 3: 27 October, 2pm EST / 7pm GMT / 8pm CET
Who should attend:
  • HCPs
  • Pharma employees interested in learning more about aggregate reports and reporting requirements for medicinal products
Agenda:
  • Introduction of the Aggregate reports types
  • Overview of different types of Aggregate reports: DSUR, PSUR/PBRER, PADER/PAER, ACO
  • In-depth look into the legal framework
  • Q&A session as time to ask our experts any questions

 

About our expert speakers:

Dr. Vjera Bilušić Vundać
Director of Medical Writing, PrimeVigilance

 

Vjera has over 20 years of experience in scientific pharmaceutical research, pharmacovigilance, regulatory affairs, and quality and spent the last decade in managerial and directorial roles in both the pharma industry and pharma service providers. Her experience includes working with all range of medicinal products, from generics to originals, biosimilars, vaccines, and blood derivates, covering both safety and regulatory aspects of medicinal product life-cycle.

 

Jana Dančíková, MD
Strategic Advisor, PrimeVigilance

 

Jana has over 14 years of experience in pharmacovigilance, mainly in preparation of periodic safety reports and signal detection. She has worked with several global pharmaceutical companies as well as service providers. She joined PrimeVigilance in 2020 and currently holds the position of Strategic Advisor, working closely with the Medical Writing Department.

 

If you have any questions about our webinar please feel free to contact us 

EVENT – World Drug Safety Congress Europe

The World Drug Safety Congress Europe will bring together drug safety, pharmacovigilance, data analytics, epidemiology, and other key players in the biopharma sector. Explore the use of big data and AI in pharmacovigilance, examine benefit-risk management strategies and patient-centric approaches; discuss how you can tackle the challenges of social media and drug safety legislation globally.
PrimeVigilance will be there, if attending please stop by and meet our Executive and Commercial Teams at Booth #12 to discuss your pharmacovigilance and drug safety needs.
If you want to set up a meeting with the PrimeVigilance team, you can do so by emailing us at marketing@primevigilance.com.
We are looking forward to welcoming you to our booth!
For more information about this event, please visit: https://lnkd.in/gj8-pf6
 
 

NEWS – New Free Educational Regulatory Webinar

This new webinar aims for our regulatory experts to present and provide our listeners with a good understanding of the regulatory framework for compassionate use. Our webinar will guide you through a few examples of requirements, varying across different countries and regions. You will dive into the principles for adverse events reporting in compassionate use and how the requirement differs (or not) from those in clinical trials.

Choose between one of 3 sessions available for this webinar:

  • Session 1: 22 September, 6am EST / 11am GMT / 12pm CET
  • Session 2: 22 September, 10am EST / 3pm GMT / 4pm CET
  • Session 3: 22 September, 2pm EST / 7pm GMT / 8pm CET

Who should attend:

  • Pharma/Biotech Industry Regulatory Team
  • Regulatory Intelligence Team
  • Clinical Regulatory Team Members
  • Pharmacovigilance Regulatory Team Members

Key learnings include:

  • Introduction to the regulatory framework for compassionate use
  • Regulators’ approach to the provision of unlicensed medicines for unmet medical needs: legal definitions and conditions
  • Differences between named patient basis and cohort/group approach
  • The divergent regulatory landscape in EEA and US
  • Regulatory challenges in the implementation of Compassionate Use Programmes (CUP)

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

 

About our expert speakers:

Marcelina Rybianska

Ergomed, Regulatory Affairs Associate Director, Strategy

Marcelina has 15 years of experience in global regulatory affairs, supporting Sponsor companies in the execution of successful regulatory strategies for their clinical research programs. She provides Ergomed clients with regulatory solutions and consultancy services across a variety of projects and therapeutic indications.

Tatjana Kosec, MSc

PrimeVigilance, Associate PV Manager, PV Regulatory Intelligence

 

Tatjana is a pharmacovigilance regulatory intelligence expert with extensive knowledge of safety reporting requirements associated with medicinal products in clinical trials, authorised for marketing or made available through special access programmes. She joined PrimeVigilance in 2018 with more than 10 years of working experience in executive government institutions and became involved in continuous development of corporate proprietary intelligence system which now covers 150 countries.

If you have any questions  about our webinar please feel free to contact us 

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