Welcome to our team of dedicated troubleshooters

Check out our details and get in touch

Susanne Felumb,
CEO and QA Manager, MSc. Pharm

Susanne is the owner and CEO of PharmAdvice, and has more than 20 years of experience in the international pharmaceutical industry with QA and regulatory affairs.

Further details —>

Christina Guiton, Pharmacovigilance Manager, QPPV, MD, MSc. Pharm Med

Christina Guiton is a medical doctor with more than 20 years of experience within the pharma industry.

Since 2005, Christina’s focus has been on pharmacovigilance, ranging from case handling, through periodic reports, safety surveillance, risk management plans, Pharmacovigilance System Master File (PSMF), compliance and deputy QPPV

Further details —>

Ea Dige, Pharmacovigilance Manager, MD

Ea has more than 20 years of experience from the international pharmaceutical industry with special focus on post-marketing safety surveillance, surveillance of safety during clinical trials and previous experience as Medical Assessor at the Danish Health and Medicines Authority.

Further details —>

Lotte Gam Kristensen,
Pharmacovigilance Manager, DVM, PhD

Lotte has more than 10 years of experience from the Danish Medicines Agency within the fields of pharmacovigilance, marketing authorisations and life-cycle management of veterinary medicinal products. Lotte has a broad basis of veterinary expertise, including a PhD degree and clinical experience.

Further details —>

Gitte Villadsen,
Drug Safety Associate

Gitte has more than 25 years in the pharmaceutical industry with solid experience within Global Pharmacovigilance, GCP/GLP QA, Clinical Trial Operations, Global Strategic Outsourcing and R&D functions.

Further details —>

Tina Nørgaard,
QA Manager, RP, Tenders and Marketing Compliance, MSc. Pharm, MPA, Lead Auditor

Tina has more than 30 years of experience in international pharmaceutical companies with focus on marketing and business management. Long experience and responsibility in Marketing Compliance and in QMS and GDP compliance as RP and lead auditor. Tina has a strong commitment to create sustainable solutions for customers in a variety of therapeutic areas as well as large experience in tender and public affairs management.

Further details —>

Laila Frederiksen,
Regulatory Affairs Officer

Laila has more than 10 years of experience from the international pharmaceutical industry within regulatory affairs with focus on life cycle management and marketing compliance.

Further details —>

Rikke Baltzar,
PA to CEO and Regulatory Affairs Assistant

Rikke has extensive experience from the pharmaceutical industry within medical, pharmacovigilance, medical device and marketing areas.

Rikke has a solid basis of professional language, communication and administrative support.

Further details —>

Highlights of qualifications

Susanne Ølsgaard Felumb

More than 20 years of experience from international pharmaceutical industry, QA and regulatory affairs. Special focus has been on quality assurance (qualified person), marketing compliance and regulatory affairs covering a wide range of regulatory affairs activities such as regulatory strategies, project management, marketing authorisation applications, life cycle management and eCTD submissions.

During the years I have worked with biological medicinal products, vaccines, herbal medicinal products and medicinal products for human and veterinary use.

    • Development of regulatory strategies

    • Project management of development projects

    • Preparation of IMPDs for clinical trial applications

    • Preparation, compilation and submission of regulatory applications

    • eCTD submissions

    • Due diligence of dossiers

    • TSE/BSE expert

    • Quality expert

    • Experienced in preparation of SmPC, leaflets and labelling

    • Participation in scientific advices with competent authorities

    • Lifecycle management of existing products

    • Trained in databases for tracing of change control, document management system, regulatory information, and artwork

    • Qualified Person responsible for batch release of blood products

    • Qualified Person responsible for batch release of herbal medicinal products

    • Review and approval of documentation including master records, working instructions and SOPs

    • Deviations and CAPAs

    • Change control requests

    • Rules and regulations for promotion of medicinal products set by authorities and the pharmaceutical industry in the Nordic countries

    • Current legislation and code of ethics regarding communication and advertising to health care professionals (HCPs) and the general public

    • Review of promotional material ensuring compliance with current legislation and code of ethics

    • Management experience as Regulatory Affairs Manager for 19 employees at Statens Serum Institut from 2007 to 2010

    • Managing Director and owner of PharmAdvice since July 2017

Accomplishments

  • MSc. Pharm, the Faculty of Pharmaceutical Sciences, University of Copenhagen, 1996

    • 2017 - present
      PharmAdvice ApS, CEO

    • 2015 - present
      PharmAdvice ApS, QA Manager

    • 2015 - 2016
      PharmAdvice ApS, Qualified Person

    • 2011 - 2017
      PharmAdvice ApS, Regulatory Affairs Manager

    • 2007 - 2010
      Statens Serum Institut, Regulatory Affairs Manager

    • 2000 - 2007
      Statens Serum Institut, Regulatory Affairs Officer

    • 1998 - 2000
      Statens Serum Institut, Qualified Person

    • 1996 - 1998
      H:S Apoteket, Hospital Pharmacy, Clinical Pharmacist

    • 2022, EudraCon meeting, Graz

    • 2017, DIA Euromeeting 2017, Glasgow (DIA)

    • 2016, DIA Euromeeting 2016, Hamburg (DIA)

    • 2012, DIA Euromeeting 2012, Copenhagen (DIA)

    • 2022, Root cause analysis (Pharmakon, Denmark)

    • 2021, Pharmacovigilance systems master file (Atrium, Denmark)

    • 2019, GMP-update 2019/2020 (ECA/Concept Heidelberg)

    • 2019, Promotion in the Nordics (Atrium)

    • 2019, Signal detection and management (Pharmadanmark)

    • 2019, New requirements for drug-drug device combination products and medical device (Pharmadanmark)

    • 2019, The future in Regulatory affairs – digitalization, robots and AI (Pharmadanmark)

    • 2019, Serialisation (Pharmadanmark)

    • 2018, Pharmacovigilance inspections (Pharmadanmark)

    • 2018, Communication and advertising to the public and HCP and marketing compliance network (Atrium)

    • 2019, Serialisation (Pharmadanmark)

    • 2017, GDPR – for life science (Atrium)

    • 2016, Falsified medicines directive (LIF)

    • 2015, GMP training (Pharmakon)

    • 2015, Module 9: Product life cycle activities (Medicademy)

    • 2015, QP – qualified person – GMP update, challenges and dilemmas (Pharmakon)

  • Supplementary training in regulatory affairs, eCTD-submission, regulatory strategies, GMP, validation, pharmaceutical production and QA/QC records and reports, microbiology, immunology, vaccinology, TSE/BSE, regulatory writing and management courses

Education & credentials

Contact details

For an initial talk, please feel free to contact Susanne directly.

Highlights of qualifications

Christina Guiton

Medical doctor with over 20 years of experience within Pharma. Starting with several years in Clinical Development and Regulatory, moving thereafter across to Medical Writing and Medical Affairs. Since 2005, focus has been on Pharmacovigilance, ranging from case handling, through periodic reports, safety surveillance, risk management plans, Pharmacovigilance System Master File (PSMF), compliance, and (deputy) QPPV.

Therapeutic areas: dermatology, endocrinology, fertility, general medicine, oncology, orphan drug areas (e.g., short bowel syndrome), psychiatry & neurology, respiratory.

    • Adverse Event report handling in clinical trials and post marketing setting

    • Medical monitoring & oversight during planning and execution of clinical development pro-grammes

    • Reconciliation of SAEs in databases

    • Literature surveillance/search

    • Developmental Safety Update reports

    • Periodic Safety Update Reports (PSURs)

    • Risk Management Plans (RMPs)

    • Post-Authorisation Safety Studies (PASS)

    • Safety surveillance, incl. QPPV participation in cross functional safety and labelling committees

    • Preparation of safety communication to competent authorities and medical community

    • Pharmacovigilance System including PSMF

    • Inspection of PV system by competent authorities

    • Health hazard evaluations

  • Safety information in SmPCs/PILs

  • Authorship of clinical study reports, clinical expert reports, clinical overviews, clinical summaries

  • Safety & Pharmacovigilance Line manager across several companies, latest heading up QPPV Office (4 employees)

Accomplishments

    • MD, University of Copenhagen, 1990

    • M.Sc. Pharm. Med, University of Surrey, UK, 2013

    • 2022 - present
      PharmAdvice ApS, QPPV, Pharmacovigilance Manager

    • 2019 - 2022

      AstraZeneca, Deputy (EU & UK) QPPV

    • 2018 - 2019

      Larix (CRO), DK, Director, Pharmaco-vigilance

    • 2016 - 2018

      Merck KGaA, Germany, QPPV Officer and Deputy EEA QPPV

    • 2015 - 2016

      Merck KGaA, Germany, QPPV Officer

    • 2014 - 2015

      Actavis, DK, Deputy QPPV, Pharma-covigilance Drug Safety Europe/Rest of World

    • 2013 - 2013

      Actavis, DK, Dept. Manager, Pharma-covigilance Drug Safety Europe/Rest of World

    • 2012 - 2013

      Leo Pharma, DK, Principal Medical Adviser, Medical/ Clinical Dept.

    • 2008 - 2012

      Actavis, DK, Business Supporter, Pharma-covigilance Drug Safety Europe/Rest of World

    • 2007 - 2008

      H. Lundbeck, DK, Head of Department, International Safety & Pharmacovigilance

    • 2006 - 2007

      H. Lundbeck, DK, Section Leader, International Safety & Pharmacovigilance

    • 2005 - 2006

      H. Lundbeck, DK, Senior Medical Reviewer, International Safety & Pharma-covigilance

    • 2003 - 2005

      H. Lundbeck, DK, Medical Adviser, Medical Affairs Mood Disorders

    • 2001 - 2003

      H. Lundbeck, DK, Section Head, Medical Writing

    • 1997 - 2001

      H. Lundbeck, DK, Medical Writer, Medical Writing

    • 1997 - 1997

      Novo Nordisk, DK, Medical Adviser, Strategic Business Unit

    • 1995 - 1996

      Novo Nordisk, DK, Medical Information Manager, Medical Information

    • 1992 - 1995

      Novo Nordisk, DK, Graduate Trainee, Medical/Regulatory/ Marketing Depts.

    • 1992 - 1992

      Nykøbing Falster Hospital, DK, Postgraduate house officer, General practitioner

    • 1991 - 1992

      KAS Glostrup, DK, Postgraduate house officer, Orthopaedic Surgery

    • 1990 - 1991

      Nykøbing Falster Hospital, DK, Postgraduate house officer, Medical Dept.

    • 1990 - 1990

      KAS Glostrup, DK, Postgraduate house officer, Medical dept.

    • 2022 Nordic Pharmacovigilance Day (Life Science Academy)

    • 2018 Medical Device Training/Management Forum

    • 2018 eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD)/EMA

    • 2017 Eleventh stakeholder forum on the pharmacovigilance legislation (EMA)

    • 2017 Good Clinical Practice for Clinical Trials/Merck KgaA

    • 2017 QPPV Toolbox, your key your success/ DIA (NDA Group, Shelley Ghandi)

    • 2014 European Forum for Qualified Person for Pharmacovigilance, London (DIA)

    • 2014 Improving Processes & CAPA (corrective & preventive action) Management Forum (Dr. Laura Brown)

  • Supplementary in-house training as part of hired positions in GCP, Pharmacovigilance (including EMA GVP)

Education & credentials

Contact details

For an initial talk, please feel free to contact Christina directly.

Highlights of qualifications

Ea Dige

Medical Doctor with experience from the pharmaceutical industry in the Pharmacovigilance area since 1992. I have been lead Medical advisor in CNS, cardiac and allergy clinical development projects. I have served as QPPV for human medicinal products and have working experience from clinical trial and post-marketing safety surveillance both from the USA and Denmark.

    • Adverse Event report handling in clinical trials and post marketing setting

    • Medical oversight during planning and execution of clinical development programmes

    • Reconciliation of SAEs in databases

    • Literature surveillance/search

    • Developmental Safety Update reports

    • Periodic Safety Update Reports

    • Chairing cross functional safety and labelling committees

    • Pharmacovigilance System including PSMF

    • Implementation of new PV database system

    • Experienced presenter at PV courses

    • Preparation of safety communication to competent authorities and medical community

    • Inspection of PV system by competent authorities

    • Certification from EMA for electronic submission of ICSRS, and of information on medicines

    • Pharmacovigilance for veterinary product

  • Head of Pharmacovigilance department, ALK-Abello A/S - 8 employees

Accomplishments

  • MD, University of Copenhagen, 1984

    • 2015 - present
      PharmAdvice ApS, QPPV, Pharmacovigilance Manager

    • 2014 – 2014
      Danish Health and Medicines Authority, Senior Medical officer

    • 2002 – 2014
      ALK-Abelló A/S, Post-marketing safety and clinical trials in allergy and respiratory disorders, Director and QPPV, Global Clinical Development man. team

    • 2001 - 2002
      Aventis Pharmaceuticals, Pharmacovigilance, Clinical trials in cardiology, Director

    • 1998 – 2001
      Johnson & Johnson Pharma (Research Institute), Pharmacovigilance, Clinical trials in CNS, metabolism, Associate Director / Director

    • 1992 – 1996 Novo Nordisk HQ, International Pharmacovigilance and Safety, Drug Safety Advisor

    • 1991 – 1992
      Novo Nordisk HQ, International Medical Affairs, Medical Database advisor

    • 1985 – 1991
      Danish Municipal Data Center, Senior consultant – Hospital information systems

    • 1984 – 1985 Copenhagen County Hospital, Internist

    • 2020 DIA –European Forum for Qualified Persons for Pharma-covigilance -3 days, virtual

    • 2020 Life Science Academy: Nordic PhV day – 1 day, virtual

    • 2020 Brookwood; PV for Local safety Contact and L-QPPV – 1 hour

    • 2019 Life Science Academy: Nordic PhV day – 1 day -Copenhagen

    • 2019 DIA –European Forum for Qualified Persons for Pharmaco-vigilance (2 days)

    • 2019 MSSO: Coding with MedDRA -1 day

    • 2018 Life Science Academy: Nordic PhV day –1 day Copenhagen

    • 2018 DIA –European Forum for Qualified Persons for Pharmaco-vigilance (2 days)

    • 2017 GCP update/brush-up - Larix

    • 2017 Life Science Academy: Pharmacovigilance challenges, Hot topics in 2017 – 1 day

    • 2017 Management Forum – Advanced Veterinary Pharmaco-vigilance (2 days)

    • 2015-2017 DIA – European Forum for Qualified Persons for Pharmaco-vigilance (2 days) - Annual

    • 2015 Life Science Academy: Nordic PV day – Copenhagen – 1 day

    • 2011 Nordic Pharmacovigilance Conference – Stockholm -1 day

    • 2009-2013 Course leader for 2 modules of the Medicademy Pharmacovigilance Diploma course

    • 2008-2013 DIA –European Forum for Qualified Persons for Pharmacovigilance (2 days) -Annual

    • 2008 DIA /FDA/PhRMA Drug Safety Conference

  • Participation in meetings regarding aspects of pharmacovigilance, arranged by network of the Danish Medicines Agency and the Danish Association for the Pharmaceutical Industry

Education & credentials

Contact details

For an initial talk, please feel free to contact Ea directly.

Highlights of qualifications

Gitte Villadsen

More than 25 years in the pharmaceutical industry with solid experience within Global Pharmacovigilance, GCP/GLP QA, Clinical Trial Operations, Global Strategic Outsourcing and R&D functions.

Accomplishments

  • • Weekly literature search and evaluation

    • Handling of cases via EMA and MHRA

    • Case handling including, data entry, narrative writing, MedDRA coding, expectedness determi-nation, medical evaluation, quality control, follow-up requests in clinical trial cases, post-marketing surveillance study cases and post marketing cases

    • Working with various safety databases including eCRFs

    • Submission of cases via different submission portals

    • SAE reconciliation

    • PSMF ad hoc tasks

    • Compliance tracking

    • Preparation and submission of aggregate reports, line listings and annual reports

    • Writing of deviations

    • PSURs, SOPs, Working instructions – review and maintenance

    • Development and maintenance of Safety Systems processes

    • Contributor during Inspections and PV Audits

    • PV legislation, reporting requirements and timeframes

  • • Solid experience in development and management of various types of contracts related to the following areas: Pharmacovigilance, Clinical Trial Operations, Regulatory, CMC, Clinical Trial Supplies

  • • Support function to Clinical Study Managers re. various Danish and International studies

    • Solid experience in documentation tasks ie protocols, reports, Trial Master File maintenance

  • • Planning, performing and reporting re. GLP audits

    • Solid experience in training of scientific staff in EU legislation, SOPs etc.

  • • BA English, CBS Copenhagen Business School

    • Prince2 Foundation Project Management Certification, Danish Technological Institute

    • Medical Assistant, Glostrup Hospital

    • 2023 - present
      PharmAdvice ApS, Drug Safety Associate

    • 2021 - 2023 KLIFO, Pharmacovigilance Associate

    • 2020 - 2021 Pharmacosmos, Safety Operations Manager

    • 2014 - 2020 Luncbeck A/S, Global Pharmacovigilance, Senior Safety Data Associate

    • 2011 - 2014 Takeda Pharma, Global Strategic Outsourcing, Contract Manager

    • 2006 - 2011 Nycomed (later Takeda), Global Clinical Trial Operation, CRA

    • 2004 - 2006 Nycomed ApS, Clinical Research Associate

    • 2001 - 2004 Ferrosan A/S, PA to CEO

    • 1997 - 2000 Leo Pharma, R&D QA, GLP Auditor

    • 1995 - 1997 Leo Pharma, International Medical Dept., CRA

    • 1993 - 1995 Guy’s Hospital, London, Oncologisk J.C. Gazet, Medical Research Associate

  • 2023: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course, DIA

    2022: GCP refresher course, Klifo

    2021: Veeva Vault safety database online training including eCRF training

    2021: PV247 safety database training, KLIFO

    2020: BaseCon safety database training. Pharmacosmos

    2019: DIA, Excellence in Pharmacovigilance, Amsterdam

    2019: Safety Suite training, ARISg upgrade, Lundbeck

    2017: MedDRA coding, Lundbeck

    2017: CAPA training, Lundbeck

    2017: GCP refresher course, Lundbeck

    2015: GCP refresher course, Lundbeck

    2015: Drug Safety and Pharmacovigilance, LIF

    2014: Safety Suite training, ARISg upgrade Lundbeck

    2014: ARISg training, Lundbeck

    2014: LEAN-introduction

    2013: Good Clinical Practice Refresher, Takeda

    2006: Mandarin (EDMS system), Nycomed

    2005: Clinical Research and GCP refresher, Brookwood International Academy, UK

    1997: Certificate GLP, Brookwood International Academy, UK

    1995: Certificate in Clinical Research, GCP 1 + GCP 2, Brookwood International Academy, UK

Education & credentials

Contact details

For an initial talk, please feel free to contact Gitte directly.

Highlights of qualifications

Lotte Gam Kristensen

Doctor of Veterinary Medicine with experience from Danish Medicines Agency in area of pharmacovigilance, marketing authorisation and life-cycle management since 2006.

Lotte has been the Danish representative in Pharmacovigilance Working Party and Efficacy Working Party under CVMP (Committee for Veterinary Medicinal Products) in the European Medicines Agency.

Has a broad basis of veterinary expertise, including a PhD degree and clinical experience.

    • Assessment and reporting of adverse event reports

    • Signal management

    • Literature surveillance

    • Preparation of Annual safety reports

    • Preparation of Periodic Safety Update Reports

    • Preparation and maintenance of Pharmacovigilance System Master Files

    • Preparation of Risk Management Plans

    • Danish representative in Pharmacovigilance Working Party under CVMP in the European Medicines Agency in 2009 and from 2017-2018

    • Preparation and review of SmPC, leaflets and labelling

    • Clinical assessment

    • Pre-clinical assessment

    • Lead assessor in various centralised and decentralised procedures (analgetics and endocrinological products)

    • Danish representative in Efficacy Working Party under CVMP in the European Medicines Agency from 2008-2011 and 2013-2017

  • Life-cycle management of authorised veterinary medicinal products

    • Assessment of Periodic Safety Update Reports

    • Assessment of variations and extensions

    • Assessment of renewals

    • Review of sales material for customers

    • Management experience as Pharmacovigilance manager for 7 employees at Danish Medicines Agency from 2017 to 2018

Accomplishments

    • 2000 DVM, University of Copenhagen

    • 2006 PhD, University of Copenhagen

    • 2019 - present
      PharmAdvice ApS, Pharmacovigilance Manager

    • 2006 - 2018
      Danish Medicines Agency, Scientific Officer

    • 2003 - 2006
      University of Copenhagen, Faculty of Science, PhD student, research assistant and lecturer

    • 2000 - 2002
      Esbjerg Dyreklinik / Taastrup Dyreklinik, Veterinary practitioner

    • 2019 Nordic Pharmacovigilance Day.
      “Hot topics”. Increasing awareness of significant and essential needs in Pharmacovigilance

    • 2009 European Association for Veterinary Pharmacology and Toxicology. Leipzig, Germany

    • 2021 Webinar for MAHs on The Veterinary Medicines Regulation (EU) 2019/6, Swedish Medical Products Agency

    • 2020 Pharmacovigilance – an introduction, Pharmakon, Hillerød

    • 2020 PV for the Local Safety Contact and L-QPPV, Online Training Program, Brookwood Global, UK

    • 2020 Know PV, Online Training Program, Brookwood Global, UK

    • 2019 Pharma Advertising and Information – BASIC, Atrium, Copenhagen. Pharma Interaction (Basic) – Meeting and Training HCPs, Atrium Copenhagen

    • 2019 Coding with MedDRA, MSSO course, LEO Pharma, DK

    • 2016 Workshop in Basic Pharmaco-kinetics, by Professor Malcolm Rowland (University of Manchester, England), Arosa, Switzerland

    • 2007 - 17 Various EMA assessor training courses within safety surveillance, preclinical and clinical assessment of veterinary medicinal products

    • 2005 PhD courses: Statistics for Veterinarians and Laboratory Animal Sciences

    • Project management, Implement Consulting Group, Copenhagen, DK

Education & credentials

Contact details

For an initial talk, please feel free to contact Lotte directly.

Highlights of qualifications

Tina Nørgaard

I have more than 30 years of experience in international pharmaceutical companies with focus on marketing and business management. Long experience and responsibility in Marketing Compliance and in QMS and GDP compliance as RP and lead auditor.

I have a strong commitment to create sustainable solutions for customers in a variety of therapeutic areas as well as large experience in tender and public affairs management.

    • GDP responsibility for > 20 years as RP and lead auditor

    • More and 15 years as quality responsible in various pharma companies

    • Development and set up of Quality Systems in and for various companies

    • Project management of QMS projects

    • Quality Due diligence .

  • • Large experience in writing of compliant marketing materials, patient materials, medical let-ters etc

    • Knowledge of the Nordic regulations of marketing compliance

    • Reviews and compliance assurance of marketing materials in the Nordics

    • Thorough therapeutic knowledge of Allergy, Respiratory Diseases, Gastroenterology, Hae-matology, Cancer, Dermatology, Movement Disorders, Epilepsy

    • Large experience with patient communication and organization

  • • Responsible for Regulatory Affairs during >15 years on Nordics markets

    • Responsible for compliant reporting of PV in organizations and for Nordic medical literature monitoring

  • • Large experience in Public Management and handling of authority replies/letters

    • Large experience in tender management

Accomplishments

  • • MSc. Pharm, Copenhagen University

    • Master of Public Administration (MPA), Copenhagen Business School

    • IRCA certified Lead auditor (ISO), Bureau Veritas Denmark

    • 2023 - present PharmAdvice ApS, Marketing Compliance and QA Manager, RP

    • 2021 - 2023
      Campora, Consultant and owner

    • 2021 - 2023
      ALK-Abello, Sr Compliance Manager

    • 2012 - 2020

      Desitin Pharma, Mgr. director DK + SE

    • 2007 - 2012

      Cephalon Pharma, Nordic Director

    • 2005 - 2007

      Business Unit Mgr. Nordics

    • 2002 - 2005

      Novo Nordisk, Corporate Brand Mgr.

    • 2001 - 2002

      GSK, Product Manager

    • 1991 - 2002

      Astra / MedCom, Product/Market Manager

  • Multiple conferences in a variety of therapeutic areas over the years:

    • European Respiratory Society (ERS)

    • American Gastroenterological Association (AGA)

    • European Haematology Association (EHA)

    • European Academy of Dermatology and Venerology (EADV)

    • International League against Epilepsy (ILAS)

    • TOXINS, INA

    • Patient Education 2000

  • 2023 Qualification and Validation, Pharmakon

    2023 GDP II, Pharmakon

    2021 Qualification and Validation, Pharmakon

    2019 GMP update, ALK

    2018 Nordic Pharmaregulations update. NordicQA Forum

    2017 GDPR, Plesner, Cph

    2017 Nordic Pharmaregulations update. NordicQA Forum

    2015 GDP II, Pharmakon

    2012 GDP II, Pharmakon

    2006 GDP II, Pharmakon

Education & credentials

Contact details

For an initial talk, please feel free to contact Tina directly.

Highlights of qualifications

Laila Frederiksen

I have more than 10 years of experience from the pharmaceutical industry, Regulatory Affairs. Focus has been on life cycle management for a variety of products and business units.

During the years I have also been involved in the compiling and submission of applications for new MAs, and launch of new products, primarily for the Danish market.

  • Obtaining and maintaining marketing authorizations for nationally approved products (NP), MRP / DCPs and CP products:

    • Launch of new products

    • Preparing and submitting variations

    • Translation of Product Information: SPC, Labelling and Package Leaflet

    • Handling of Artwork

    • NeeS and eCTD submissions.

    • Review of promotional material aimed at health care professionals (HCPs) and the general public ensuring compliance with current legislation and code of ethics (ENLI code)

    • Handling of abbreviated SmPCs (pligttekster).

Accomplishments

  • 1987 - 1992 Danish School of Pharmacy

    • 2020 - present PharmAdvice ApS, Regulatory Affairs Officer

    • 2013 - 2019
      Sanofi A/S, Regulatory Affairs Manager

    • 2005 - 2011 Actavis A/S, Regulatory Affairs Officer

    • 2002 - 2005
      At home caring for at heartsick child

    • 2001 - 2002
      Danish Medicines Agency, Tempory position

    • 2000 - 2001
      Ferrosan A/S, Technical support

    • 1995 - 2000
      ALK-Abello A/S, Pharmaconomist, Quality Control

    • 1994 - 1995
      A/S Polymers Reconstructive, Pharmaconomist, Quality Control and Microbiological Control

    • 1992

      Dumex A/S, Project employee, Sterile ward

  • 2006 - 2010 Training at Pharmakon A/S, Hillerød: Regulatory affairs departments' secretaries and assistants, Marketing authorisations for medicinal products, 1. and 2. part; Printed packing materials, Maintenance of marketing authorisations for medicinal products; Variation applications

    2014 - 2016 Training at Pharmakon A/S, Hillerød: GDP 1 – Basic; Labeling and package leaflets - from legal requirements to layout; GDP- requirements for the transport of medicinal products; Counterfeit medicinal products - how can we avoid them?; Licensing of medicinal products - Regulatory tips and tricks

    2016 Training at Atrium, Copenhagen: MCA 1: Promotion of Medicinal Products towards Healthcare Professionals

    2017 Training at Atrium, Copenhagen: MCA: Communication and advertising to the public

Education & credentials

Contact details

For an initial talk, please feel free to contact Laila directly.

Highlights of qualifications

Rikke Baltzar

Extensive experience from the pharmaceutical industry within medicinal, pharmacovigilance, medical device and marketing areas.

Solid basis of professional language, communication and administrative support.

    • First-hand assessment of adverse events

    • Registration of adverse events in database

    • Preparation of reports on adverse events for information to affiliates and authorities

    • Language revisions, translations and proofreading of texts, e.g., scientific articles, marketing material and general text

    • Personal assistant and secretarial experience, incl. calendar management, meeting and event planning, travel and hotel booking, agenda and minutes of meetings

    • Contact to collaboration partners, authorities and affiliates

    • Processing of invoices and budget follow-up, purchasing of office equipment etc.

Accomplishments

    • English / German Commercial Correspondent (BA) from Copenhagen Business School

    • 2019 - present
      PharmAdvice ApS, PA to CEO and Regulatory Affairs Assistant

    • 2018 – 2019
      Technical University of Denmark, Administrative Assistant

    • 2007 – 2018
      ALK-Abelló A/S, Administrative Coordinator/PA to Senior VP

    • 1999 – 2007
      Coloplast A/S, Department Secretary/PA

    • 1990 – 1999
      Novo Nordisk A/S, Product Safety Assistant

    • 1985 – 1990
      Dumex A/S, Marketing Secretary

    • 1982 – 1985
      Danbrew A/S, Project Secretary

  • 2019 Writing for the Internet, Danske Sprogseminarer

    2019 Training in Internal Audit, Teknologisk Institut

    2014 Economy and financial understanding, Price Waterhouse Coopers

    2013 Proofreading course (English), Danske Sprogseminarer

    2012 Proofreading course (Danish), Danske Sprogseminarer

    2012 Project Management, Mannaz

    • 2006 Social structures and values, Copenhagen Business School

    • 2005 Medical English, Copenhagen Business School

Education & credentials

Contact details

For an initial talk, please feel free to contact Rikke directly.