Regulatory Rapporteur

Search the full Regulatory Rapporteur archive (TOPRA members only)

Write for Regulatory Rapporteur

Regulatory Rapporteur Author Guidelines

Regulatory Rapporteur September 2018

In This Issue

  • FOCUS - Chemistry, Manufacturing and Controls
  • Plus
  • Professional development in regulatory affairs
  • Paediatric studies: advancing child health?

Regulatory Rapporteur July/August 2018

In This Issue

  • FOCUS - Regulatory affairs careers
  • PLUS
  • How to commercialise advanced therapies in the EU
  • GDPR: reducing data breaches and litigation

Regulatory Rapporteur June 2018

In This Issue

  • FOCUS - Real world data/real world evidence
  • PLUS
  • Drugs for neglected diseases – a collaborative initiative
  • Meeting report: Innovative medicines and early access

Regulatory Rapporteur May 2018

In This Issue

  • FOCUS - Veterinary medicines
  • PLUS
  • Medical device regulation: Why further guidance is needed

Regulatory Rapporteur April 2018

In This Issue

  • FOCUS – Medical devices
  • PLUS
  • Navigating the devices field: Insights on the evolving requirements and innovations in medical devices
  • Clinical trial transparency within the pharmaceutical industry: Clear as mud?

Regulatory Rapporteur March 2018

In This Issue

  • FOCUS - Regulatory science
  • PLUS
  • The Paediatric Regulation: Ten years of experience reviewed
  • In conversation with the EU Heads of Medicines Agencies
  • The latest updates on medical device standards

Regulatory Rapporteur February 2018

In This Issue

  • FOCUS – Inspection readiness
  • PLUS
  • Overcoming obstacles in orphan drug development
  • Initiatives for regulatory convergence in Asian countries

Regulatory Rapporteur January 2018

In This Issue

  • FOCUS - Nonclinical studies
  • PLUS
  • An overview of differing switch processes in Europe
  • Aims for global veterinary regulatory alignment

Regulatory Rapporteur December 2017

In This Issue

  • 2017 Annual Symposium
  • PLUS
  • Medical device standards update

Regulatory Rapporteur November 2017

In This Issue

  • FOCUS - North America
  • PLUS
  • African medicines regulatory harmonisation
  • Best practices in regulatory information management

Regulatory Rapporteur October 2017

In This Issue

  • FOCUS - Early access to medicines
  • PLUS
  • Considerations for biologics marketing applications
  • Interview: In conversation with the MHRA’s Dr Ian Hudson

Regulatory Rapporteur September 2017

In This Issue

  • FOCUS - Clinical trials
  • PLUS
  • Strategic implications of the new device & IVD regulations
  • Vaccines: specific requirements and EudraLex guidance

Regulatory Rapporteur July/August 2017

In This Issue

  • FOCUS – RoW regulatory environments
  • PLUS
  • Integrating paediatric studies – the challenges continue
  • Interview: a wealth of experience in the veterinary sector

Regulatory Rapporteur June 2017

In This Issue

  • FOCUS - Advanced therapies
  • PLUS
  • The use of autogenous vaccines in the veterinary sector
  • Concerns for drug-device borderline classifications

Regulatory Rapporteur May 2017

In This Issue

  • FOCUS - Older populations
  • PLUS
  • Updates on the current status of medical device standards
  • How a QPPV should implement oversight and delegation
  • Views on the flourishing parallel imports market

Regulatory Rapporteur April 2017

In This Issue

  • FOCUS – Falsified medicines
  • PLUS
  • Developments in the EU referrals procedure: Ten years on Conducting Phase I clinical research in the EU versus US
  • Discussions on the adaptive pathways concept

Regulatory Rapporteur March 2017

In This Issue

  • FOCUS - Chemistry, manufacturing & controls
  • PLUS
  • The benefits of worksharing for veterinary variations
  • Meeting report: The Annual EMA Review of the Year

Regulatory Rapporteur February 2017

In This Issue

  • FOCUS - Pharmacovigilance
  • PLUS
  • Veterinary medicines – an Asian perspective
  • Update on medical device standards

Regulatory Rapporteur January 2017

In This Issue

  • FOCUS – Biotechnology
  • PLUS
  • Insights on the EU’s paediatric research networks
  • Proposed changes to feed additives legislation

Regulatory Rapporteur December 2016

In This Issue

  • FOCUS: TOPRA Annual Symposia 2016
  • PLUS:
  • Effectiveness of risk minimisation materials and the role of regulatory affairs: Part 2

Regulatory Rapporteur November 2016

In This Issue

  • FOCUS - North America
  • PLUS
  • Proposals for new veterinary medicines legislation
  • Views on the effectiveness of risk minimisation tools

Regulatory Rapporteur October 2016

In This Issue

  • FOCUS – Electronic submission portals
  • PLUS
  • Collaboration on falsified medicines across the EU
  • Optimising pathways for timely access to medicines

Regulatory Rapporteur September 2016

In This Issue

  • FOCUS – Global health initiatives
  • PLUS
  • Interview: Hugo Hurts, Executive Director, MEB
  • Regulatory considerations for 3D printingHEALTHCARE

Regulatory Rapporteur July/August 2016

In This Issue

  • FOCUS - Over-the-counter medicines
  • PLUS
  • Considerations for veterinary vaccine development
  • Orphan drug designation – a blueprint for success

Regulatory Rapporteur June 2016

In This Issue

  • FOCUS - Advances in healthcare
  • PLUS
  • The increasing convergence of medicines and devices
  • Biosimilar medicines: a filgrastim case study

Regulatory Rapporteur May 2016

In This Issue

  • FOCUS - Medical devices
  • PLUS
  • Veterinary medicines: EMA/IFAH-Europe InfoDay
  • The value of patents for regulatory strategies

Regulatory Rapporteur April 2016

In This Issue

  • FOCUS - Veterinary medicines
  • PLUS
  • Are paediatric data useful for vaccine development?
  • Interview: Lena Björk, Medical Products Agency
  • Reporting on the benefits of orphan medicines

Regulatory Rapporteur March 2016

In This Issue

  • FOCUS - Asia Pacific regulatory environment
  • PLUS
  • Meeting report: The EMA’s annual review of the year
  • Interview: Heidi Marchand, FDA Assistant Commissioner

Regulatory Rapporteur February 2016

In This Issue

  • FOCUS - Early access to medicines
  • PLUS
  • Advice for small and medium-sized enterprises
  • The new functionality of the PSUR repository
  • Interview: Anja Holm, CVMP Chair

Regulatory Rapporteur January 2016

In This Issue

  • FOCUS – Best practices in regulatory documentation
  • PLUS
  • IDMP: Moves towards regulatory compliance
  • Evaluating risk management materials
  • Nonclinical initiatives for line extensions

Regulatory Rapporteur December 2015

In This Issue

  • FOCUS - TOPRA Annual Symposium 2015
  • REPORTS ON
  • Human Pharmaceuticals
  • Medical Devices
  • Veterinary Medicines
  • SME Day

Regulatory Rapporteur November 2015

In This Issue

  • FOCUS - North America
  • PLUS
  • Combination products: Improving user safety
  • Trends in outourcing regulatory affairs functions

Regulatory Rapporteur October 2015

In This Issue

  • FOCUS - Clinical trials
  • PLUS
  • Devices: A unified approach to unannounced audits
  • Interview: Prof Dr med Karl Broich, BfArM President

Regulatory Rapporteur September 2015

In This Issue

  • FOCUS - Biosimilar medicines
  • PLUS
  • Toxicological approaches to impurities
  • Risk management for medical devices
  • Regulating generic veterinary medicines

Regulatory Rapporteur July/August 2015

In This Issue

  • FOCUS - Borderline products
  • PLUS
  • Cosmetics versus biocides
  • Functional food regulation in China
  • Legal precedents up for interpretation

Regulatory Rapporteur June 2015

In This Issue

  • FOCUS – Combination products
  • PLUS
  • Preparing submissions across the EU and US
  • Veterinary medicines: EMA/IFAH-Europe Info Day

Regulatory Rapporteur May 2015

In This Issue

  • FOCUS - Advanced therapies
  • PLUS
  • Global biosimilars development
  • Harmonising stability requirements
  • Packaging in the veterinary arena

Regulatory Rapporteur April 2015

In This Issue

  • FOCUS - Lifecycle management
  • PLUS
  • Conducting clinical trials in Jordan
  • Health Canada: New legislation reviewed
  • An interview with Dr Esther Werner, PEI

Regulatory Rapporteur March 2015

In This Issue

  • FOCUS - Japan's regulatory environment
  • PLUS
  • PMDA consultation meetings
  • Japan’s SAKIGAKE initiative
  • Nonclinical safety assessment
  • Medical devices regulation

Regulatory Rapporteur February 2015

In This Issue

  • FOCUS - Orphan drugs
  • PLUS
  • Clinical trial transparency under review
  • Parallel or sequential EU/US dossier preparation?

Regulatory Rapporteur January 2015

In This Issue

  • FOCUS – Health technology assessment
  • PLUS
  • Data protection issues in the medical devices arena
  • Meeting report: The future for biosimilars

Regulatory Rapporteur December 2014

In This Issue

  • FOCUS - TOPRA Annual Symposium
  • PLUS
  • A common platform for ASMFs?
  • Earlier access to medicines

Regulatory Rapporteur November 2014

In This Issue

  • FOCUS - North America
  • PLUS
  • An interview with Axel Thiele, BfArM
  • The EU Clinical Trial Regulation

Regulatory Rapporteur October 2014

In This Issue

  • FOCUS - Innovation
  • PLUS
  • Trial master files: Avoiding inspection blues
  • Is your device a laser product, and is it compliant?

Regulatory Rapporteur September 2014

In This Issue

  • FOCUS - Veterinary Medicines
  • PLUS
  • An interview with Xavier De Cuyper, FAMHP
  • Pharmaceutical vs therapeutic equivalence

Regulatory Rapporteur July/August 2014

In This Issue

  • FOCUS - Chemistry, Manufacturing & Controls
  • PLUS
  • Lean stability strategies
  • Can GMP lead to drug shortages?
  • Challenges of mixed or co-processed excipients

Regulatory Rapporteur June 2014

In This Issue

  • FOCUS - Regulatory compliance
  • PLUS
  • The MHRA herbals registration scheme
  • Ukraine’s regulatory framework

Regulatory Rapporteur May 2014

In This Issue

  • FOCUS – Falsified medicines
  • PLUS
  • Personalised medicines
  • Veterinary strategies
  • Advice from HTA bodies

Regulatory Rapporteur April 2014

In This Issue

  • FOCUS - Transparency
  • PLUS
  • EMA review of 2013 and outlook for 2014
  • Residual metals harmonisation challenges
  • INFARMED annual conference report

Regulatory Rapporteur March 2014

In This Issue

  • FOCUS - Paediatric medicines
  • PLUS
  • Interview: Dr Tomas Salmonson, CHMP Chair
  • The EMA /HTA parallel scientific advice initiative
  • Perspectives on voluntary harmonisation

Regulatory Rapporteur February 2014

In This Issue

  • FOCUS: Middle East and Africa
  • PLUS
  • Benefit–risk assessment
  • US & EU submission planning
  • Veterinary pharmacovigilance

Regulatory Rapporteur January 2014

In This Issue

  • FOCUS - Global regulatory strategy
  • PLUS
  • A guide to environmental risk assessment
  • DIA Annual Meeting: regulatory sessions reviewed

Regulatory Rapporteur December 2013

In This Issue

  • Focus – TOPRA Annual Symposium reports
  • PLUS
  • Strategies for global submissions from the US
  • Piloting the common EU submission platform

Regulatory Rapporteur November 2013

In This Issue

  • FOCUS: US Update
  • PLUS
  • Medical devices: Proposed new biocompatibility testing strategies under the spotlight
  • The advantages of change management protocols

Regulatory Rapporteur October 2013

In This Issue

  • FOCUS - Pharmacovigilance
  • PLUS
  • Biosimilars in the Latin American environment
  • Improving outcomes for paediatric patients
  • Innovation in drug development and regulation

Regulatory Rapporteur September 2013

In This Issue

  • FOCUS - Latin America
  • PLUS
  • Roundtable: Review of the veterinary medicines legislation
  • Meeting report: 11th EGA international symposium on biosimilars

Regulatory Rapporteur July/August 2013

In This Issue

  • FOCUS - Geriatric medicines
  • PLUS
  • Measuring benefit–risk
  • Challenges in paediatric medicines
  • Progress on global harmonisation
  • A modern approach to document management

Regulatory Rapporteur June 2013

In This Issue

  • FOCUS - Regulatory resources & management
  • PLUS
  • The value of observational studies
  • A quantum leap in diagnostics legislation
  • Benefits of PAT-based submissions
  • Veterinary sector developments

Regulatory Rapporteur May 2013

In This Issue

  • FOCUS - Clinical trials
  • PLUS
  • Switching medicinal products to OTC status
  • DIA EuroMeeting: reports on selected sessions

Regulatory Rapporteur April 2013

In This Issue

  • FOCUS - Advanced Therapies
  • PLUS
  • Case study: first vaccine approval via Article 58
  • A review of biosimilar monoclonals guidance
  • Regulators’ recommendations on scientific advice

Regulatory Rapporteur March 2013

In This Issue

  • FOCUS - Over-the-counter medicines
  • PLUS
  • How regulatory intelligence can ensure compliance
  • Managing submissions through process mapping

Regulatory Rapporteur February 2013

In This Issue

  • FOCUS - Targeted therapies: A US perspective on attaining approvals for personalised medicines and companion diagnostics
  • PLUS
  • Meeting report: Annual EMA Review of the Year
  • Update on global harmonisation initiatives
  • Travelling the regulatory career path

Regulatory Rapporteur January 2013

In This Issue

  • FOCUS - Biotechnology
  • PLUS
  • Healthcare 'apps' as medical devices?
  • The new pharmacovigilance master file format
  • Concerns on veterinary legislation revision

Regulatory Rapporteur December 2012

In This Issue

  • FOCUS – TOPRA Annual Symposium 2012
  • Pharmaceutical symposium
  • Medical devices symposium
  • Veterinary medicines symposium
  • SME Day

Regulatory Rapporteur Nov 2012

In This Issue

  • FOCUS - US Update
  • PLUS
  • Views on the proposed new devices legislation
  • Plans to harmonise benefit–risk methodology
  • The evolving rules on GMO use in clinical trials

Regulatory Rapporteur Oct 2012

In This Issue

  • FOCUS - Drug development
  • PLUS
  • The struggle for paediatric orphan products
  • Addressing drug shortages in North America
  • Canada: Update on international initiatives
  • Medical devices: Notified body audits

Regulatory Rapporteur Sep 2012

In This Issue

  • FOCUS - Chemistry, Manufacturing and Controls
  • PLUS
  • The evolution of QbD – from inception to maturity in 2012
  • A case for standardising regulatory excipient evaluation
  • Towards improved patient safety – issues and solutions in implementation of the new pharmacovigilance legislation

Regulatory Rapporteur Jul/Aug 2012

In This Issue

  • Focus – Regulatory Intelligence
  • PLUS
  • The World Wide Web as the ultimate regulatory intelligence database
  • Draft regulations, guidances, or guidelines: providing consolidated comments and proposals to health authorities and trade associations
  • A comparison of ASEAN and Chinese drug registration requirements

Regulatory Rapporteur June 2012

In This Issue

  • Focus - Benefit–risk
  • PLUS
  • Nonclinical aspects of biosimilar development – A regulatory perspective
  • Changes to EN 60601-1 and how to maintain MDD compliance
  • Nutraceuticals and functional food regulations in key emerging markets: Part 2 – Specifics

Regulatory Rapporteur May 2012

In This Issue

  • Focus - Clinical Trials
  • PLUS
  • Perceptions and realities of clinical safety of biosimilars – Part 2
  • Nutraceuticals & functional food regulations in key emerging markets
  • The new Medicinal Products and Health Products Safety Reform Act

Regulatory Rapporteur April 2012

In This Issue

  • Focus – Emerging markets
  • PLUS
  • Perceptions and realities of clinical safety of biosimilars – EU and
  • The code of conduct for notified bodies
  • The Medical Devices Exchange

Regulatory Rapporteur March 2012

In This Issue

  • Focus: Pharmacovigilance legislation
  • PLUS
  • A clarity call for the definition of ‘metabolic means’
  • Australia update: The evolving new business process
  • MEDDEV post-market clinical follow-up studies

Regulatory Rapporteur February 2012

In This Issue

  • Focus: Veterinary medicines
  • PLUS
  • EMA Annual Review 2011/2012 - Session reports
  • Synthesising electronic document management
  • EU regulatory update tables

Regulatory Rapporteur January 2012

In This Issue

  • Editorial: 2012 - a 'recast' in more ways than one
  • Focus: Medical devices and technology
  • Nonclinical aspects of biosimilar development
  • Requirements governing medicines promotion in the EU

Regulatory Rapporteur December 2011

In This Issue

  • Focus: Annual Symposium reports
  • Editorial: Delivery innovation to patients
  • Review of the new EMA draft guideline
  • Medical Devices exchange

Regulatory Rapporteur November 2011

In This Issue

  • Editorial: Leading from the front
  • Focus: Regulatory management and leadership
  • First in-human UK clinical trials: quality requirements
  • Changes to veterinary pharmacovigilance legislation

Regulatory Rapporteur October 2011

In This Issue

  • Medicines for children
  • Focus: Paediatrics
  • Regulatory agency transparency
  • Medical Devices exchange

Regulatory Rapporteur September 2011

In This Issue

  • FDA’s Bad Ad programme
  • US drug safety reforms
  • A new pathway for biosimilars
  • Views from industry
  • Canada news in brief

Regulatory Rapporteur July/August 2011

In This Issue

  • FOCUS: CRITICAL STEPS FOR ADVANCED THERAPIES
  • PLUS:
  • Classifications of topical treatments
  • The IVD medical devices directive
  • Lifecycle management

Regulatory Rapporteur June 2011

In This Issue

  • Information & communication technology
  • Submitting dossiers in Japan
  • Russia’s regulatory environment
  • Advertising medicinal products
  • Audits & inspections: preparation

Regulatory Rapporteur May 2011

In This Issue

  • The true value of regulatory intelligence – and how to apply it to strategic eff ect
  • PLUS
  • A unique view of EMA–FDA collaboration
  • Disharmony in the medical devices arena?

Regulatory Rapporteur April 2011

In This Issue

  • HEALTH ECONOMICS – A BAPTISM OF FIRE?
  • Insights from key stakeholders on approaches to health technology assessment

Regulatory Rapporteur March 2011

In This Issue

  • STREAMLINING EU LEGISLATION
  • New perspectives on clinical research and the Voluntary Harmonisation Procedure

Regulatory Rapporteur February 2011

In This Issue

  • WHEN WORLDS COLLIDE - MERGERS & ACQUISITIONS
  • The role of regulatory affairs in M&As
  • Switching ownership of an MA
  • Manufacturing site rationalisation

Regulatory Rapporteur January 2011

In This Issue

  • Back to biotechnology basics
  • Biotech CMC reviewed – 5 years on
  • Are biosimilar MAbs feasible?

Regulatory Rapporteur December 2010

In This Issue

  • 2011 AND BEYOND
  • News and views from expert speakers gathered at TOPRA’s Annual Symposium 2010

Regulatory Rapporteur November 2010

In This Issue

  • VARIATIONS ON A THEME
  • The EU variations system – an industry view
  • Organisational models for CMC dossiers
  • Are you suff ering from registration drift?

Regulatory Rapporteur October 2010

In This Issue

  • INNOVATION
  • Forging new regulatory pathways
  • Biosimilar biologics
  • Adaptive trial designs

Regulatory Rapporteur September 2010

In This Issue

  • NORTH AMERICA’S REGULATORY LANDSCAPE
  • FDA’s electronic submissions gateway
  • Primary IND applications
  • Due diligence
  • Canada update

Regulatory Rapporteur July Aug 2010

In This Issue

  • PHARMACOVIGILANCE
  • Charting adverse events in Austria
  • The importance of safety data in PILs
  • PLUS:
  • Interview: Dr Hartmut Krafft, Co-Chair of the CTFG
  • Update on traditional herbal medicines legislation
  • Should GI control techniques be reappraised?

Regulatory Rapporteur June 2010

In This Issue

  • HELPING CHILDREN DECIDE
  • The Paediatric Regulation – three years on
  • A guide to establishing ‘informed assent’
  • Study support: National research networks

Regulatory Rapporteur May 2010

In This Issue

  • REGULATING MEDICAL TECHNOLOGIES
  • Human tissue engineering
  • Software as a medical device?
  • Classification of IVF media

Regulatory Rapporteur April 2010

In This Issue

  • Exploring biomarker techniques
  • Nonclinical guidance on anticancers
  • Working with radiation

Regulatory Rapporteur March 2010

In This Issue

  • Beyond the petri dish
  • Strategies for early phase studies
  • Exploratory trial approaches
  • Fast-to-patient options

Regulatory Rapporteur February 2010

In This Issue

  • Reflections on Asia - India’s Eastern promise
  • A new dawn for China
  • PLUS
  • Good review practices in the UK
  • Inside Slovenia’s regulatory agency

Regulatory Rapporteur January 2010

In This Issue

  • A paperless network in 2010? Migrating into PIM format - The promise of eCTD
  • Science-driven guidance for IMPDs
  • Good review practices in Canada
  • Medicinal product, or medical device?

Regulatory Rapporteur December 2009

In This Issue

  • Regulators and industry speak on CHMP reviews, ATMPs, paediatrics, pharmacovigilance, medical devices, veterinary products and more...
  • PLUS Good review practices – focus on the FDA

Regulatory Rapporteur November 2009

In This Issue

  • Counterfeiting: the global threat to patient health - Regulators tackle internet trafficking
  • PIP tips – A ready reference on paediatric investigation plans
  • Australia accelerates reforms

Regulatory Rapporteur October 2009

In This Issue

  • Regulators revisit the PIL
  • User testing
  • A pharmacist’s perspective

Regulatory Rapporteur September 2009

In This Issue

  • VARIATIONS:
  • The new classifications
  • CMD(h) expectations
  • A new legal framework
  • PLUS:
  • Quality by design – the role of the CMC professional
  • Regulatory update on Canada

Regulatory Rapporteur July/August 2009

In This Issue

  • Regulatory principles and practices for advanced therapies
  • Stem cell therapy regulations – US vs EU
  • Somatic cell therapies – quality aspects of an IMPD
  • Interview: Inside Sweden’s regulatory agency, the MPA
  • A guide to Japan’s clinical trial consultation system

Regulatory Rapporteur June 2009

In This Issue

  • Focus on chemistry, manufacturing and controls – REACH | Disintegration testing | Medicines for children | CMC compliance | Biotech product characterisation
  • Report on the joint TOPRA-EU Commission Meeting

Regulatory Rapporteur May 2009

In This Issue

  • Conducting paediatric trials
  • A step-by-step guide to defining a PIP strategy
  • Regulatory challenges in global trials
  • The future of the EU Clinical Trial Directive
  • Inside the National Research Ethics Service

Regulatory Rapporteur April 2009

In This Issue

  • Drug safety, medication safety, patient safety
  • FDA draft guidance on genotoxic and carcinogenic impurities
  • Adverse event reporting to institutional review boards
  • Insight on the CDER’s review process for QT studies

Regulatory Rapporteur March 2009

In This Issue

  • FOCUS: NEW MEDICINES LEGISLATION
  • Veterinary pharmacovigilance in action
  • Orphan drug activities in Australia, Canada and Japan
  • Inside the Swedish Medical Products Agency

Regulatory Rapporteur February 2009

In This Issue

  • The role of the EudraVigilance database
  • Veterinary vigilance: continuing safety assessments
  • A guide to establishing medical device vigilance systems in the EU
  • Interview with Dr June Raine, head of the MHRA’s Vigilance Risk Management of Medicines division
  • The genesis of the Purple Guide

Regulatory Rapporteur January 2009

In This Issue

  • Regulating biotech’s moving frontier
  • Radio-labelled drugs: a science-driven approach to IMPDs
  • Inside the Greek regulatory agency

Regulatory Rapporteur December 2008

In This Issue

  • Reports on the 5th Annual TOPRA Symposium
  • Reports on parallel symposia

Regulatory Rapporteur November 2008

In This Issue

  • A meeting of minds: the burgeoning relationship between the US and EU orphan drug agencies
  • Patient power: inside Eurordis, the European organisation representing rare disease patients
  • A guide to orphan product pre-launch requirements in the EU

Regulatory Rapporteur October 2008

In This Issue

  • Focus on eCTD and the electronic evolution
  • The medicinal product and medical device borderline
  • A NICE approach to improving healthcare – an interview with Professor Sir Michael Rawlins

Regulatory Rapporteur September 2008

In This Issue

  • Reflections on the Hungarian National Institute of Pharmacy – an interview with Professor Tamás Paál
  • PIL user testing – the vital role of the volunteers
  • EMEA workshop on modelling in paediatric medicines

Regulatory Rapporteur July/ August 2008

In This Issue

  • Focus on quality: investigational medicinal products, expiry dating for solid drug products
  • BROMI variations
  • Second EMEA Workshop for SMEs

Regulatory Rapporteur June 2008

In This Issue

  • Focus on herbal medicines
  • Electronic submissions in the UK
  • Decentralised Procedure - experience and advice

Regulatory Rapporteur May 2008

In This Issue

  • Non-clinical testing of therapeutic antibodies: the question of the relevant animal species
  • Inside the Dutch Medicines Evaluation Board
  • MHRA Annual Conference 2008

Regulatory Rapporteur April 2008

In This Issue

  • Regulatory affairs in Japan - an update
  • UK post-market surveillance and vigilance for medical devices
  • The European Food Safety Authority and its activities

Regulatory Rapporteur March 2008

In This Issue

  • New Regulation for Advanced Therapies
  • The work of the EMEA Innovation Task Force
  • Which RMS/Rapporteur?

Regulatory Rapporteur February 2008

In This Issue

  • The future of medicines legislation in Europe
  • Inside the Estonian Agency
  • ISO 15378:2006 - a challenge for the medical device industry
  • GMP Desk Audits

Regulatory Rapporteur January 2008

In This Issue

  • Transatlantic co-operation on medicines regulation
  • The Darwinian evolution of regulatory affairs
  • Risk management in medical devices

Regulatory Rapporteur December 2007

In This Issue

  • TOPRA Symposium reports: Pharmaceutical, Veterinary, Medical Technology
  • Inside the Bulgarian Agency
  • Regulatory Intelligence updates

Regulatory Rapporteur November 2007

In This Issue

  • Rational decision making
  • How much time is spent on Lifelong Learning programmes?
  • Notified Bodies in medical technology

Regulatory Rapporteur October 2007

In This Issue

  • Pharmacovigilance in Central and East Europe
  • Inside the FDA: interview with Murray Lumpkin
  • A bridge too far for PIL compliance?

Regulatory Rapporteur September 2007

In This Issue

  • Referrals and arbitration
  • Pharmacovigilance: PSUR submissions
  • Canada: Maple Leaf News
  • Nutrition and health claims for foods

Regulatory Rapporteur July-August 2007

In This Issue

  • Paediatric regulations and risk management plans – TOPRA’s second North American Symposium reviewed
  • Interview with Jytte Lyngvig, CEO Danish Medicines Agency
  • What’s new in electronic submissions?

Regulatory Rapporteur June 2007

In This Issue

  • Using Positron Emission Tomography (PET) microdosing
  • Regulatory affairs in Japan
  • Lifelong Learning: developing your own brand

Regulatory Rapporteur May 2007

In This Issue

  • First-in-man studies: key publications reviewed
  • MedDRA codes – how often do companies update them?
  • Applying scientific standards to readability user testing

Regulatory Rapporteur April 2007

In This Issue

  • Changing to eCTD – an end to the paper chase?
  • The changing image of regulatory affairs
  • User testing: can industry meet the deadline?
  • Twinning – learning from each other in the EU

Regulatory Rapporteur March 2007

In This Issue

  • Countering the counterfeiters
  • Preparing for REACH
  • Pharmacovigilance: Seriousness criteria for ADR reporting

Regulatory Rapporteur February 2007

In This Issue

  • Osteoporosis Drugs: CHMP guidelines welcomed
  • Working together: how can agencies improve international collaboration on drug evaluation
  • Writing clinical overviews

Regulatory Rapporteur January 2007

In This Issue

  • Focus on pharmacovigilance
  • Improving the safety of phase I clinical trials
  • Regulatory updates from Canada, Turkey and Portugal

Regulatory Rapporteur December 2006

In This Issue

  • New EU Regulation on paediatric medicines
  • Quality Systems approach to GMP for medical devices
  • Salaries in Regulatory Affairs

Regulatory Rapporteur November 2006

In This Issue

  • TOPRA Symposium reports
  • Aginus Kalis interviewed
  • Preparing for electronic submission

Regulatory Rapporteur October 2006

In This Issue

  • Effects of drug pricing policies
  • Key competences for regulatory affairs professionals
  • Devices: moving to ISO 13485: 2003

Regulatory Rapporteur September 2006

In This Issue

  • Legislation on medicinal gases
  • Review of the Prescription Drug User Fee Act
  • Named patient supply
  • Continuing Personal Development

Regulatory Rapporteur July-August 2006

In This Issue

  • Focus on complementary/alternative medicines
  • Inaugural meeting of TOPRA North America
  • Regulation of ophthalmic products

Regulatory Rapporteur June 2006

In This Issue

  • Multilingual product information
  • Avian influenza
  • EU Devices directives update
  • Open eCTD forum

Regulatory Rapporteur May 2006

In This Issue

  • European risk management strategy
  • Incentives for SMEs
  • 10 years of EMEA CNS submissions - a rapidly acting sleep inducing agent
  • Consistency of Scientific Advice

Regulatory Rapporteur April 2006

In This Issue

  • Future regulation of Advanced Therapy Produ
  • Interview with Dr pekka Kurki
  • User testing of PILs
  • Regulatory Intelligence Update

Regulatory Rapporteur March 2006

In This Issue

  • Advanced Therapy Medicinal Products
  • Homeopathic Medicines
  • Increase your word power - biotechnology definitions
  • Re-use of single devices
  • 10 years of EMEA CNS medicines - a new dual action antidepressant

Regulatory Rapporteur February 2006

In This Issue

  • The role of immunoassays and bioassays
  • Impact of new pharamaceutical legislation
  • Pre-clinical challenges facing cell-based medicinal products

Regulatory Rapporteur January 2006

In This Issue

  • Focus on immunotoxicity guidelines
  • Assessing carcinogenicity in the absence of standard rodent carcinogenicity data
  • The value of regulatory information in clinical research
  • 10 years of EMEA CNS medicines - Anti-dementia treatments

Regulatory Rapporteur December 2005

In This Issue

  • Focus on The 2nd TOPRA Annual Symposium
  • The MHRA - plans for the future: Interview with Professor Kent Woods
  • The Clinical Trial Directive - national implementation status

Regulatory Rapporteur November 2005

In This Issue

  • Focus on promotional activities. What are the rules?
  • Mutual Recognition and Decentralised Procedures - interview with Shirley Norton
  • 10 years of EMEA CNS Medicines - Antipsychotic treatments

Regulatory Rapporteur October 2005

In This Issue

  • The lexicon of US regulatory affairs
  • The Phase I/II and II/III interface in drug development
  • The regulation of combination products

Regulatory Rapporteur September 2005

In This Issue

  • 10 years of EMEA CNS medicines
  • Intelligent approaches to safety evaluation
  • Implementing risk management

Regulatory Rapporteur July/ August 2005

In This Issue

  • Development programme for a biosimilar medicinal product
  • User testing of Package Leaflets
  • XML language

Regulatory Rapporteur June 2005

In This Issue

  • The eCTD readiness of the EU
  • Is eCTD needed?
  • eCTD: The burden and the benefits

Regulatory Rapporteur May 2005

In This Issue

  • Interview with Daniel Brasseur
  • Getting better medicines to children
  • European framework for children's medicines

Regulatory Rapporteur April 2005

In This Issue

  • European medical technology legislation and healthcare product development
  • NICE's IPP
  • Eucomed and key regulatory challenges

Regulatory Rapporteur March 2005

In This Issue

  • POM to P switching
  • Personal and career development
  • Germany: experience of clinical trials legislation

Regulatory Rapporteur February 2005

In This Issue

  • Communicating with blind patients
  • Biogenerics: Non-clinical aspects
  • Comparability of biotech products

Regulatory Rapporteur January 2005

In This Issue

  • Gene therapy: myths and pitfalls
  • FDA guidelines on sterile drug products
  • New EU medicines legislation

Regulatory Rapporteur December 2004

In This Issue

  • GM foods: a European perspective
  • New EU Medicines Legislation
  • Devices: John Williams interviewed

Regulatory Rapporteur November 2004

In This Issue

  • TOPRA/EU Commission conference on medicines legislation
  • Stem cell research: the science, and ethics and regulatory issues
  • Applying for a clinical trial in Germany

Regulatory Rapporteur October 2004

In This Issue

  • EU Directive on Traditional Herbal Medicinal Products
  • Update on Australian Regulations
  • Abridged regulatory procedures

Regulatory Rapporteur September 2004

In This Issue

  • Computer systems validation
  • Switching from "POM" to "P"
  • European Medicines Agency updates

Regulatory Rapporteur August 2004

In This Issue

  • Environmental risk assessment of pharmaceuticals
  • MHRA scientific advice: How are the new procedures working?
  • ICH update

Regulatory Rapporteur July 2004

In This Issue

  • Health economics across Europe
  • Back to Basics: European regulatory guidelines for human medicines
  • Maple Leaf News

Regulatory Rapporteur June 2004

In This Issue

  • Clinical Trials Directive: Separating fact from fiction
  • EU accession: How has the regulatory framework changed?
  • An introduction to health economics

Regulatory Rapporteur May 2004

In This Issue

  • Brussels and London launch for TOPRA
  • Gaining orphan status in the EU
  • Clinical Trials Directive after May 1st

Regulatory Rapporteur April 2004

In This Issue

  • Malta: preparing for EU accession
  • National implementation of the Clinical Trial Directive
  • Orphan Medicinal Product status in the EU

Regulatory Rapporteur March 2004

In This Issue

  • The future direction of the EMEA – interview with Thomas Lönngren
  • Guest editorial: David Jeffreys
  • Back to Basics: Principles of development genetics

Regulatory Rapporteur February 2004

In This Issue

  • Biogenerics: Development and regulatory hurdles
  • Parallel importation of devices in the EU
  • The Exchange: Your questions answered

Regulatory Rapporteur January 2004

In This Issue

  • Regulatory challenges of EU enlargement
  • Anti-cytokine treatment for rheumatoid arthritis
  • Back to basics: Regulation of medical devices in Europe
Syndicate content