Validation Protocol:

Content Related to Validation Protocol



• Bringing Innovation to Clinical Design Clinical trials may be one of the most fundamental parts of drug development work carried out in the pharmaceutical industry, but they still remain a complicated area for pharma companies to address. The design of trials plays an important role in the process of producing the right kind of data to support applications and ensure that products take a strong step towards reaching market. In additio....Read more

  Contributor:  Pharma IQ Tags: clinical design | innovation clinical design | clinical reporting 09/29/2010  12:00:00 AM EDT

• Software Design for Medical Devices Software is playing an increasing role within the development of medical devices and the pharmaceutical industry as a whole. Amendments to the Medical Devices Directive mean that, in certain circumstances, software itself is considered to be a medical device. According to the European Commission, the changes to the directive reflect the fact that "software is in its own right a med....Read more

  Contributor:  Pharma IQ Tags: software design for medical devices | medical devices | medical device software 10/04/2010  12:00:00 AM EDT

• Cross-Validation of Bioanalytical Methods: When, Why and How? Bioequivalence studies are extremely important for the pharmaceutical industry to ensure that generic drugs are up to standard, and make their way to the market in a timely manner. Around two-thirds of clinical studies undertaken worldwide are to determine bioequivalence. Therefore changes in the guidelines which govern such research could have large ramifications on those working in the field of dr....Read more

  Contributor:  Pharma IQ Tags: cross-validation | bioanalytic methods | FDA guidance 07/05/2010  12:00:00 AM EDT

• What Would You Do in the Case of a Virus Breakout in Your Manufacturing Plant? The porcine circovirus contamination of GSK’s Rotarix vaccine in March of this year, and previous contaminations in both Baxter and Genzyme biological products in 2009, have highlighted the issue of viral safety in biologics more than ever before. In a recent interview Dr. Mark Plavsic, Senior Director, Gene Therapy Development Genzyme, spoke with Andrea Charles from Pharma IQ, about t....Read more

  Contributor:  Pharma IQ Tags: Mark Plavsic | viral safety | viral safety studies 09/01/2010  12:00:00 AM EDT

• Improving Biomarker Development Work Flow in Phase I Clinical Development Reto Ossola, Group Leader for Biomarker Research at Biognosys, joins Pharma IQ to discuss the main challenges in biomarker development and some key ways to address these. Ossola offers some best practice tips for assessing and working with a CRO, when entering into discovery outsourcing and collaborations. Ossola also outlines some of the different types of partnerships that Biognosys has been ....Read more

  Contributor:  Helen Winsor Tags: Reto Ossola | phase one | phase I 09/08/2010  12:00:00 AM EDT

• FDA Guidelines The pharmaceutical industry in the United States has to comply with a number of guidelines to ensure the quality of the products it manufactures, the safety of its workers and members of the public, and the environment in which it operates. Many of these are issued by the Food and Drugs Agency (FDA), which exists to protect the public's health by ensuring all foods and medical products used by h....Read more

  Contributor:  Pharma IQ Tags: FDA guidelines for bio analytical method validation | FDA guidelines for clinical trials | FDA guidelines for pharmaceuticals 09/20/2010  12:00:00 AM EDT

• 	65.2% of Pharma Professionals Need Clarity on PAT and QbD Regulation Submissions   What are the 7 Deadly Sins of Quality Assurance and Quality Control? Download our free QA QC eBook now to find out!   Whilst companies seek to embed Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives into their wider business to incre....Read more
  Contributor:  Andrea Charles Tags: PAT | QbD | Process Analytical Technology 01/18/2011  12:00:00 AM EST

• Are You Prepared for eCTD Submission? Klaus Menges, Division of Strategy and Planning, at the Federal Institute for Drugs and Medical Devices, BfArM, joins Pharma IQ, to discuss successful strategies for eCTD submission. To listen to the podcast now go to Successful Strategies for eCTD Submission. Pharma IQ: Ensuring eCTD readiness is now critical for all businesses wishing to gain first time market approval – what would you....Read more

  Contributor:  Andrea Charles Tags: eCTD | eCTD submissions | eCTD readines 02/10/2011  12:00:00 AM EST

• Pharma IQ Top Blogger Awards 2011 - Legal & Regulatory At Pharma IQ we like to share the best things in life! With that in mind we are pleased to be able to release the first in our series of Pharma IQ Top Blogger Awards. This week we name our 10 favourite regulatory and legal blogs, giving the authors the credit and recognition they deserve for their contribution to the community.We recommend that you peruse our brief descriptions below and select ....Read more

  Contributor:  Pharma IQ Tags: Legal & Regulatory | Legal | Regulatory 05/10/2011  12:00:00 AM EDT

• Change Control, You’d Better Have One! While Change Control (CC) is applied to the entire chain of events in any pharma industry, from R&D to batch release, it is the core function of any pharmaceutical plant. “Even when a change is made to improve product or process quality, change control is required”. In a pharmaceutical plant, CC is the “champion” of all other processes; CC must be a centralised opera....Read more

  Contributor:   Tags: Cristina Falcão | change control | pharmaceutical plant 06/14/2011  12:00:00 AM EDT

• Are We Entering an Age of Expensive Personalised Medicines? Since the approval of Pfizer's lung cancer drug Xalkori by the United States Food and Drug Administration (FDA), headlines have been calling into question the future of personalised medicine – and the cost it will bring with it. Pfizer's own figures suggest the drug will only be of benefit to between 6,500 and 11,000 patients in the United States who are suffering from AKL positive met....Read more

  Contributor:  Pharma IQ Tags: personalised medicines | personalised medicine research | biomarker discovery 09/20/2011  12:00:00 AM EDT

• Pfizer Animal Health: Disposable Solutions for Biomanufacturing Jay Thompson, Associate Director of Bioprocess Development at Pfizer Animal Health, discusses the impact of  the slow implementation of disposables for downstream processing and how Pfizer is getting around quality and regulatory challenges as they move towards commercialisation. Pharma IQ: What are the hot topics in disposable solutions for biomanufacturing in general right now? J Thompson....Read more

  Contributor:  James Thompson Tags: Disposable Solutions for Biomanufacturing | Pfizer Animal Health | Downstream 10/17/2012  12:00:00 AM EDT

• 	Best Practice Tips for Overcoming Obstacles in Biomarker Development How can we overcome the latest challenges in Biomarker Development? Birgitte Søgaard, Divisional Director for Clinical Pharmacology and Translational Medicine at H Lundbeck A/S, discusses with Helen Winsor from Pharma IQ, the key challenges in this area, in particular the need for
  Contributor:   Pharma IQ Tags: Birgitte Sogaard | phase 1 | phase one 07/29/2010  12:00:00 AM EDT

• Streamlining the Development and Validation Process in Discovery to Phase I Clinical Development Reto Ossola, Group Leader for Biomarket Research at Biognosys, joins Helen Winsor from Pharma IQ, to discuss phase I clinical development. He outlines where he sees the main challenges in biomarker development at the moment and discusses some key ways to address the cost-efficiency pressures. The interview

  Contributor:   Pharma IQ Tags: Reto Ossola | phase I clinical development | phase I 09/06/2010  12:00:00 AM EDT

• 	Expert Tips in Freeze Dryer Cleaning and Validation Kevin Murgatroyd, Senior Pharmaceutical Consultant and expert in the field of cleaning and validation of freeze dryers, joins Helen Winsor from Pharma IQ, to discuss lyophilisation in biologicals. Murgatroyd looks at the key criteria when cleaning freeze dryers and the regulatory requirements that must be
  Contributor:   Pharma IQ Tags: Kevin Murgatroyd | lyophilisation process | lyophilisation 12/07/2010  12:00:00 AM EST

• 	Improving PAT Validation Qualification of equipment and validation of analytical methods are critical components for the implementation of process analytical technology (PAT). Martin Warman, Scientific Fellow, Analytical Development at Vertex Pharmaceuticals, joins Andrea Charles from Pharma IQ, to discuss the effects of
  Contributor:   Andrea Charles Tags: Martin Warman | Vertex Pharmaceuticals | PAT 12/24/2010  12:00:00 AM EST

• 	The Do’s and Don’ts of Process Validation Stephen Brown, CTO of Vivalis and a Member of the Single Use Task Force, PDA, joins Helen Winsor from Pharma IQ, to discuss the application of risk management strategies when implementing single-use systems (SUS). First Brown outlines how best to implement a full SUS and the vital ingredients for
  Contributor:   Helen Winsor Tags: Stephen Brown | Vivalis | Single Use Task Force 01/12/2011  12:00:00 AM EST

• 	Best Practice Tips for Successful eCTD Submissions Yann Kervevan, EMEA Regulatory Affairs Operations Manager, Alexion Pharmaceuticals, joins Helen Winsor from Pharma IQ, to dicsuss the challenges in eCTD implementation and electronic submissions. Firstly Kervevan offers some best practice tips for industry on converting and assembling files. He reflects on
  Contributor:   Helen Winsor Tags: Yann Kervevan | Alexion Pharmaceuticals | eCTD Submissions 01/14/2011  12:00:00 AM EST

• 	Assessing the Global Impact of Standardisation on Manufacturers: Is it Really Worth it?
  Tags: Andrew Miller | pre-CDISC protocol | CDISC

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