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Home > News & Events

News & Events

Nitrosamines – Information for Marketing Authorisation Holders

20th February 2020

Webinar // Risk Management of the presence of Nitrosamines in medicines:
Regulatory expectations

18th February 2020

TOPRA Symposium 2020

12th February 2020

BIO Europe Spring 2020

12th February 2020

Forum Institut für Management: “Pharmacovigilance in Europe – Introductory webcast series”

10th February 2020

iPSpine animation launched at second annual consortium meeting

6th February 2020

PharmaLex expands compliance service offering

5th February 2020

Workplace Culture

Behavioural Culture in the Workplace

28th January 2020

Vendor Management

16th January 2020

PDA Annual Meeting 2020

16th January 2020

World Drug Safety Congress Americas 2020

16th January 2020

How to Choose the Best Quality and Regulatory Consultants

14th January 2020

Advertising Compliance for Healthcare Products

9th January 2020

Webinar // The EAEU electronic Submission Challenge

8th January 2020

PharmaLex strengthens Healthcare Compliance services

7th January 2020

EU/US Mutual Recognition Agreement for GMP Inspections

2nd January 2020

PharmaLex are in San Francisco for the
JP Morgan Healthcare week

20th December 2019

2019: Trending topics in Pharma

18th December 2019

PharmaLex joins forces with Vintura

13th December 2019

Serialisation – New EU Aide Memoire for GDP

11th December 2019

PharmaLex to plant 250 trees to celebrate its 25th anniversary

9th December 2019

Our 25th Biosimilar Molecule in Our 25th Year!

3rd December 2019

DIA RSIDM 2020

3rd December 2019

DIA Europe 2020

3rd December 2019

The shift in responsibility for determining IR35 compliance: How will it affect regulatory staffing in the UK?

27th November 2019

Objectives: New EU Medical Device and In-Vitro Diagnostic Regulations

25th November 2019

Biotech

EMA guidance on biosimilars in the EU

25th November 2019

PharmaLex Internal Audit Programme Management Services

14th November 2019

Webinar // The challenges of achieving and maintaining Regulatory CMC Compliance

12th November 2019

Technical Helpdesk Service

7th November 2019

PharmaLex shortlisted in the prestigious CPhI Pharma Awards 2019

28th October 2019

Vendor Management

14th October 2019

Serialisation “Use and Learn” phase will end on January 31st, 2020

8th October 2019

Regulations for the Cosmetic Products Industry

25th September 2019

12th Pharma Regulatory Affairs Asia 2019

17th September 2019

ClinPhlex Symposium: A Clinical Development Discussion hosted by PharmaLex

17th September 2019

Symposium – Innovative & Integrated Solution Providers in translational research to develop immunotheraphies

17th September 2019

Digitalisation in the Pharmaceutical Industry

12th September 2019

DIA Eurasia Workshop – Implementing eCTD and ICH in the Region

9th September 2019

Virtual QA and management of outsourced activities

5th September 2019

Building the eCTD in Middle East – Practical Solutions to Compile Electronic Submissions

3rd September 2019

Brexit Q&A – PharmaLex

2nd September 2019

Serialisation – Enforcement and Proposed Inspections

28th August 2019

Webinar // Vendor Management Programs – Ensuring Success!

26th August 2019

American Medical Device Summit

16th August 2019

25th Annual Validation Week

16th August 2019

ISPE Boston Product Show

16th August 2019

PDA / FDA Joint Regulatory Conference

16th August 2019

How to implement a robust Quality Risk Management Program

12th August 2019

Visual Inspection – best practices in industry and the role of artificial intelligence

6th August 2019

NLS Days 2019

5th August 2019

The EU – US Mutual Recognition Agreement What does this mean for your organisation?

24th July 2019

CMDh releases public consultation on common regulatory approaches for allergen products in Europe

18th July 2019

Cloud Computing in Pharma

10th July 2019

Quality Operations Efficiency

3rd July 2019

The importance of GxP Compliance for Global Cannabis Production

25th June 2019

Good Distribution Practices of Medicinal Products

12th June 2019

Pharmaceutical Facility Design

29th May 2019

TOPRA Annual Meeting 2019

23rd May 2019

CPhI Worldwide 2019

23rd May 2019

Webinar // ClinPHLEX – A Strategically-Focused, Cross-Functional, Clinical Development Partnership

23rd May 2019

QRM requirements from Draft Annex 1

22nd May 2019

Webinar // Safety considerations for an Rx to OTC Switch Program

21st May 2019

FDA Inspection Readiness – is your company ready?

13th May 2019

Brexit: Guidance on Batch Testing

9th May 2019

Quality Considerations for Continuous Manufacturing in the Pharmaceutical Industry

30th April 2019

Top Tips – Building your ISO Quality Management System

24th April 2019

Webinar // An Overview to Non clinical testing: why? when? what?

17th April 2019

EU Guidance on the Implementation of the Medical Devices and In-Vitro Diagnostic Medical Devices Regulations

3rd April 2019

EU Advice on Fluroquinolone Antibiotics – Use and Adverse Reactions

28th March 2019

PharmaLex selected as regulatory partner for 15m EUR EU Horizon 2020 project to design novel therapy

27th March 2019

European Commission Goals for Sustainability in the Pharmaceutical Industry

21st March 2019

Keeping Up-to-date with Pharmacovigilance System Requirements in the Event of No-Deal Brexit

12th March 2019

New Guidance on Classification of Good Manufacturing Practice Deficiencies

11th March 2019

Training Course: Jordan – Building the eCTD

7th March 2019

European Commission issued QC Test Exemption for the EU post March 29th, 2019

6th March 2019

Training Course: eCTD in the Middle East

5th March 2019

Brexit

Staying compliant in both the EU and the UK after “Brexit”

27th February 2019

Brexit Checklist for the Pharma Industry

26th February 2019

Top 10 Tips for an effective Internal Audit System

20th February 2019

Use and Learn Period for Serialisation

14th February 2019

Cleaning Validation

13th February 2019

Brexit: Update for the Pharma Industry

7th February 2019

How can you add value to your Self-Inspection Programme?

30th January 2019

Webinar // Early Phase Modelling – Estimating the Costs and Effectiveness of a Pharmaceutical before Clinical Trial

25th January 2019

Forbes Leader’s Talk: The Challenges of the Biotech Market

23rd January 2019

Brexit Readiness

22nd January 2019

DIA Pharmacovigilance and Risk Management Strategies Conference 2019

18th January 2019

Top Tips for Reduction of SOP Complexity

15th January 2019

BEBPA Bioassay Conference 2019

14th January 2019

DIA RSIDM 2019

14th January 2019

DIA Annual Meeting 2019

14th January 2019

SQA 2019

14th January 2019

Update to the EU Code of Practice for the Responsible Person for GDP

8th January 2019

International Conference on Pharmacoepidemiology 2019

4th January 2019

CPhI US 2019

3rd January 2019

RAPS 2019

3rd January 2019

BIO International Convention

3rd January 2019

MedCon 2019

3rd January 2019

Outsourcing in the Pharmaceutical Industry

18th December 2018

Meaningful Metrics

11th December 2018

Webinar // Overview of the Biotech Drug Development Pathway

5th December 2018

Continued supply of medicines to patients in the UK post-Brexit

4th December 2018

Understanding the Impact of Culture and Behaviours on Data Integrity Compliance

28th November 2018

Pharmaceutical Serialisation – Are you Ready?

23rd November 2018

TRAC Services, part of PharmaLex UK, reach £40K in donations to charity

15th November 2018

Can an Appropriate Risk-Benefit Assessment Help Drug Availability?

15th November 2018

CPhI India 2018

15th November 2018

IABS 2018

15th November 2018

BioWin Day 2018

13th November 2018

HPRA Guide Update to “Notification of Marketing Status of Human Medicines”

8th November 2018

PharmaLex and A.R.C. Pharma join to strengthen existing regulatory consulting capabilities in France

1st November 2018

HPRA Guide Update to “Batch-Specific Requests for Human Medicines”

1st November 2018

PharmaLex supports ORPHELIA Pharma to achieve PUMA for Kigabeq®

29th October 2018

HPRA Guide Update to “Labels and Leaflets of Human Medicines”

23rd October 2018

BioMotiv and PharmaLex establish preferred partnership

17th October 2018

PharmaLex.pert Lisa Pascoe gets TOPRA Distinguished Service Award

10th October 2018

How is Brexit impacting Pharma ?

10th October 2018

DIA Europe 2019

5th October 2018

Immunogenicity & Bioassay Summit

5th October 2018

Points to consider for a Robust Contamination Control Strategy

5th October 2018

Global Regulatory Affairs Summit BERLIN

2nd October 2018

CPHI Worldwide

2nd October 2018

TOPRA Annual Meeting 2018

2nd October 2018

The Role of Process Simulation

25th September 2018

BPCI CMC Regulatory Affairs Training Programme

25th September 2018

HPRA – launches ‘The Medicine Shortages Framework’

18th September 2018

Guidance for Preparing Standard Operating Procedures (SOPs)

11th September 2018

Playing a role in Quality Culture

30th August 2018

Inspection Report – how to write an effective response

22nd August 2018

ISPE Boston Product Show

16th August 2018

Nordic Life Science Days 2018

16th August 2018

RAPS Regulatory Convergence 2018

16th August 2018

BREXIT Implementation Period for Life Sciences

8th August 2018

Biotech Atelier – the first ever of it’s kind

8th August 2018

Brexit – Guidance from PharmaLex

2nd August 2018

Data Science: Strategy For A Successful Quality By Design Implementation

31st July 2018

Environmental Risk Assessments for Human Medicinal Products – Challenges and Recent Developments

31st July 2018

An introduction to the FDA and first meeting prep advice

26th July 2018

How 2017 FDA Inspection Findings can Improve your Inspection

26th July 2018

EudraVigilance – The fundamental tool for Pharmacovigilance

20th July 2018

34th ICPE – International Conference

18th July 2018

Medical Device Software – 2 day workshop

16th July 2018

Quality Risk Management for QPs

10th July 2018

PharmaLex opens new office in Bonn

6th July 2018

MAH (Marketing Authorisation Holder) Brexit Considerations

4th July 2018

PharmaLex Group strengthens senior regulatory expertise in the Nordic region

4th July 2018

Brexit Supply Chain Risk – 5 Considerations

2nd July 2018

Human Error – some fresh approaches to consider:

27th June 2018

The key to successful Batch Record Review

12th June 2018

ISO IDMP Implementation in Europe – how SPOR will change the Regulatory Environment

1st June 2018

MEGRA Annual Conference 2018

1st June 2018

PDA Europe Conference 2018

30th May 2018

Must each container of a starting material be sampled for identification?

29th May 2018

EMIG Regulatory Group Meeting

25th May 2018

Self-Inspection – how can you add value?

22nd May 2018

The Clock is ticking on Pharmaceutical Serialisation

18th May 2018

PharmaLex US merges into single organization

17th May 2018

DIA Global Annual Meeting 2018

8th May 2018

BIO International Convention 2018

8th May 2018

FDA Publishes Q&A on GMPs for APIs

3rd May 2018

Quality Risk Management

24th April 2018

FDA 483 Observations Relating to Cleaning

24th April 2018

10 Top Tips for an effective Internal Audit System

18th April 2018

Prepare for Brexit

18th April 2018

Implementing an effective change control system

16th April 2018

Brexit: An update on preparations for MA holders

12th April 2018

34th SQA Annual Meeting & Quality College

12th April 2018

5th Biennial Biosimilars & Biobetters Congress

12th April 2018

Challenges in Supply Chain Management

11th April 2018

Good Distribution Practices Implementation Survey Findings

11th April 2018

Out of Specification Guidance – Update by MHRA

10th April 2018

New Annex 1 – Consequences for the QP

10th April 2018

Navigating Brexit – The UK’s withdrawal from the EU

29th March 2018

5-Key Elements of a Cleaning Validation Study

28th March 2018

Pharma and Life Sciences Supply Chain – hot topics

13th March 2018

Is it time to push the Hard-Brexit-Ready Button?

5th March 2018

Top Tips for Deviation Writing

27th February 2018

PharmaLex Group establishes Italian base

21st February 2018

Market Authorisation Holders – Plan Ahead for Brexit

15th February 2018

fda observations

Top Tips to Avoid the Frequent FDA Form 483 Observations

8th February 2018

Leadership Tips from Ann McGee

8th February 2018

Brexit and the Pharma Industry – January 2018 Updates

31st January 2018

GDP – US and EU Deficiencies

22nd January 2018

revision of Annex 1

Long awaited revision of Annex 1

18th January 2018

The importance of Quality and Company Culture in 2018

9th January 2018

DIA Europe 2018

8th January 2018

World Drug Safety Congress Americas 2018

5th January 2018

DIA Regulatory Submission, Information, and Document Management Forum

5th January 2018

DIA 2018 – Pharmacovigilance and Risk Management Strategies Conference

21st December 2017

Mergers & Acquisitions (M&A) related activities – A Regulatory Affairs perspective

25th November 2017

EMA to relocate to Amsterdam

23rd November 2017

PharmaLex Group expands regulatory footprint, strengthening presence in the CIS region

23rd November 2017

PharmaLex Group develops UK operations

22nd November 2017

EFPIA Publishes Survey Results on Brexit Amid Calls for Maximum Regulatory Alignment

14th November 2017

PharmaLex strengthens international executive team

11th November 2017

PharmaLex Group collaborates with Kiana Systems

9th November 2017

PharmaLex Group enters into strategic partnership with Volv Global SA

5th November 2017

PharmaLex France approved for the Research Tax Credit

5th September 2017

Judith K. Jones, MD, PhD honored by ISPE

4th September 2017

PharmaLex Group further strengthens quality management and compliance services

28th August 2017

PharmaLex Group further strengthens senior regulatory expertise

16th August 2017

Interview with David Jefferys on “Brexit – possible implications”

31st July 2017

CO.DON AG achieves remarkable outcome, receiving EU marketing authorization for Spherox

14th July 2017

PharmaLex Group strengthens biosimilar expertise

10th July 2017

PharmaLex Group expands service provision with the addition of health economics in the Nordics

4th July 2017

EMA and CMDh issue Q&As relating to Brexit

5th June 2017

The Licensing of Medicines – Consequences of UK “Brexit Vote”

31st May 2017

CMDh update guidance on RMS switch following Brexit

22nd May 2017

PharmaLex Group further strengthens quality management and compliance services

15th May 2017

Regulatory preparedness – implications of the UK leaving the EU

12th May 2017

PharmaLex Group gains momentum in the US with acquisition of The Degge Group, Ltd.

2nd May 2017

PharmaLex Group builds US presence with acquisition of Safis Solutions

24th April 2017

PharmaLex Group accelerates growth by strengthening office in Bulgaria

21st March 2017

PharmaLex Group adds Pharmacovigilance to its service portfolio in the US

31st January 2017

PharmaLex Group further strengthens its development consulting division

25th January 2017

PharmaLex Group expands its service portfolio with acquisition of Arlenda

13th January 2017

December 1st, 2016: Celebrating PharmaLex expansion with office opening in Paris, France.

7th December 2016

PharmaLex US Anounces Strategic Collaboration with Pharmaceutical Compliance Expert Howard L. Dorfman

3rd November 2016

PharmaLex to open new office in France

26th September 2016

PharmaLex continues its strong 2016 performance following the merger with Jacobsen Advice

24th August 2016

PharmaLex Group expands to the Nordic Region following merger with Lindeq AS

13th April 2016

PharmaLex Group: Establishment of affiliate in Switzerland (Basel)

1st January 2016

PharmaLex and YES Pharma Services are merging

1st October 2015
Upcoming Webinars

March 10th, 2020

Webinar // Risk Management of the presence of Nitrosamines in medicines:
Regulatory expectations

04:00 PM CET

Upcoming Events

March 17 - 19th, 2020

DIA Europe 2020

Visit us at booth J4/K4

March 23 - 25th, 2020

BIO Europe Spring 2020

Visit us at booth #51

March 23 - 25th, 2020

World Drug Safety Congress Americas 2020

Visit us at booth #15

March 30 - April 1st, 2020

PDA Annual Meeting 2020

Visit us at booth #329

October 5 - 7th, 2020

TOPRA Symposium 2020

Visit us at booth #37

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