Regulatory Rapporteur

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Regulatory Rapporteur June 2013

Volume 10 Issue 6

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

Volume 10 Issue 5

In This Issue

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

Regulatory Rapporteur April 2013

Volume 10 Issue 4

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

Volume 10 Issue 3

In This Issue

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

Regulatory Rapporteur February 2013

Volume 10 Issue 2

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

Volume 10 Issue 1

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

Volume 9 Issue 12

In This Issue

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

Regulatory Rapporteur Nov 2012

Volume 9 Issue 11

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

Volume 9 Issue 10

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

Volume 9 Issue 9

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

Volume 9 Issue 7

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

Volume 9 Issue 6

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

Volume 9 Issue 5

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

Volume 9 Issue 4

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

Volume 9 Issue 3

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

Volume 9 Issue 2

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

Volume 9 Issue 1

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

Volume 8 Issue 12

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

Volume 8 Issue 11

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

Volume 8 Issue 10

In This Issue

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

Regulatory Rapporteur September 2011

Volume 8 Issue 9

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

Volume 8 Issue 7

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

Volume 8 Issue 6

In This Issue

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

Regulatory Rapporteur May 2011

Volume 8 Issue 5

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

Volume 8 Issue 4

In This Issue

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

Regulatory Rapporteur March 2011

Volume 8 Issue 3

In This Issue

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

Regulatory Rapporteur February 2011

Volume 8 Issue 2

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

Volume 8 Issue 1

In This Issue

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

Regulatory Rapporteur December 2010

Volume 7 Issue 12

In This Issue

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

Regulatory Rapporteur November 2010

Volume 7 Issue 11

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

Volume 7 Issue 10

In This Issue

INNOVATION
Forging new regulatory pathways
Biosimilar biologics
Adaptive trial designs

Regulatory Rapporteur September 2010

Volume 7 Issue 9

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

Volume 7 Issue 7

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

Volume 7 Issue 6

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

Volume 7 Issue 5

In This Issue

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

Regulatory Rapporteur April 2010

Volume 7 Issue 4

In This Issue

Exploring biomarker techniques
Nonclinical guidance on anticancers
Working with radiation

Regulatory Rapporteur March 2010

Volume 7 Issue 3

In This Issue

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

Regulatory Rapporteur February 2010

Volume 7 Issue 2

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

Volume 7 Issue 1

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

Volume 6 Issue 12

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

Volume 6 Issue 11

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

Volume 6 Issue 10

In This Issue

Regulators revisit the PIL
User testing
A pharmacist’s perspective

Regulatory Rapporteur September 2009

Volume 6 Issue 9

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

Volume 6 Issue 7

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

Volume 6 Issue 6

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

Volume 6 Issue 5

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

Volume 6 Issue 4

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

Volume 6 Issue 3

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

Volume 6 Issue 2

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

Volume 6 Issue 1

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

Volume 5 Issue 12

In This Issue

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

Regulatory Rapporteur November 2008

Volume 5 Issue 11

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

Volume 5 Issue 10

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

Volume 5 Issue 9

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

Volume 5 Issue 7

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

Volume 5 Issue 6

In This Issue

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

Regulatory Rapporteur May 2008

Volume 5 Issue 5

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

Volume 5 Issue 4

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

Volume 5 Issue 3

In This Issue

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

Regulatory Rapporteur February 2008

Volume 5 Issue 2

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

Volume 5 Issue 1

In This Issue

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

Regulatory Rapporteur December 2007

Volume 4 Issue 12

In This Issue

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

Regulatory Rapporteur November 2007

Volume 4 Issue 11

In This Issue

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

Regulatory Rapporteur October 2007

Volume 4 Issue 10

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

Volume 4 Issue 9

In This Issue

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

Regulatory Rapporteur July-August 2007

Volume 4 Issue 7

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

Volume 4 Issue 6

In This Issue

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

Regulatory Rapporteur May 2007

Volume 4 Issue 5

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

Volume 4 Issue 4

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

Volume 4 Issue 3

In This Issue

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

Regulatory Rapporteur February 2007

Volume 4 Issue 2

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

Volume 4 Issue 1

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

Volume 3 Issue 12

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

Volume 3 Issue 11

In This Issue

TOPRA Symposium reports
Aginus Kalis interviewed
Preparing for electronic submission

Regulatory Rapporteur October 2006

Volume 3 Issue 10

In This Issue

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

Regulatory Rapporteur September 2006

Volume 3 Issue 9

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

Volume 3 Issue 7

In This Issue

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

Regulatory Rapporteur June 2006

Volume 3 Issue 6

In This Issue

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

Regulatory Rapporteur May 2006

Volume 3 Issue 5

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

Volume 3 Issue 4

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

Volume 3 Issue 3

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

Volume 3 Issue 2

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

Volume 3 Issue 1

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